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Business Development Director

December 5, 2022

Summary

The incumbent will identify, develop and nurture strategic new business relationships, identify prospects and pursue potential opportunities in order to increase awareness of Center for Breakthrough Medicines CDMO business. Primary focus will be in the pharmaceutical and biotechnology industries, NGSs and academic institutions.

Responsibilities

  • Responsible for managing the entire CDMO business cycle including identification and qualification of leads
  • Expand CBM brand awareness in the region
  • Develop and execute regional strategies to identify and target potential new customers through effective market, revenue, and literature analyses
  • Contribute to short- and long-term territory business plans through in depth understanding of revenue streams and potentials
  • Manage the territory through the use of the company relationship management tool and provide forecast reporting to management on a routine basis
  • Update and maintain the CRM database through rigorous documentation of all communications with clients and potential clients
  • Responsible for winning new customers and projects, and for maintaining repeat business
  • Participate with the business development and technical teams in the overall process for proposal generation, responding to requests for information (RFI) or proposal (RFP) and contract negotiation and closing
  • Provide management with oral and written reports on customer needs, problems, interests, competitive activities and potential for new products and services
  • Work closely with and effectively communicate with other members of the Business Development and Marketing teams, and collaboratively with internal cross functional teams (Project Management, Process Development, GMP operations, Quality and Finance)
  • Attend and actively participate in all regional industry tradeshows, conferences, networking events, and client on-site and off-site meetings, as well as internal Business Development meetings
  • Contribute to team and departmental initiatives outside of day-to-day regional sales and business and development activities
  • Accountable for meeting/exceeding performance metrics, including quarterly regional revenue goals.

Qualifications

  • Excellent organizational skills
  • Demonstrated success in developing new business and growing existing business
  • Fundamental knowledge/understanding of science and bioprocessing concepts
  • Proven ability to work in a highly collaborative environment and deal with ambiguity
  • Strong team player with the ability to make meaningful contributions to team efforts
  • Self-directed with the ability to manage a complex set of often competing priorities, needs and aggressive deadlines
  • Outstanding interpersonal and oral/written communication skills, with an emphasis on clarity and accuracy
  • Models a visible sense of urgency in accomplishing daily tasks and in coordinating with internal groups
  • Maintains a professional appearance and project and approachable/positive company image to the public

Education & Experience

  • BS in a scientific discipline, business, or related field, (MS, MBA or PhD is a plus) plus 5-8years business development or sales experience in the biopharmaceutical CDMO, pharmaceutical, biotechnology, or life science industries
  • Experience/understanding of the proposal development process, business quotes, budgeting and managing to defined timelines
  • Proficiency in MS Word and Excel. Experience with MS Project and Salesforce is a plus
  • Must be highly motivated and able to work independently
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Analytical Technical Program Leader, Testing & Analytical Services

December 2, 2022

Summary

The Center for Breakthrough Medicines is looking for Analytical Technical Program Leaders to lead our highly innovative team and add significant value to the organization. The Technical Program Leader has responsibility for the overall analytical technical programs in the Nucleic Acid, Viral Vector, and Cell Therapy asset pipeline for Testing and Analytical Development, and driving these to successful outcomes. This includes leading a cross-functional team serving as the primary technical leaders for client programs, leading successful analytical development technical transfers, and working cross-functionally with technical and operations teams to deliver technical programs. The leader will be accountable for the successful execution of the corresponding strategies in compliance with Regulatory Agency and Industry Guidance. During the clinical/commercial manufacturing preparation phase, this role will serve as a senior leader for the delivery of key product and technical operations deliverables.

Responsibilities

  • Establish and lead Technical Programs within Testing & Analytical Services at The Center for Breakthrough Medicines
  • Develop, manage, and sustain strong relationships with current and future customer accounts and represent CBM as the analytical technical program leader
  • Establish core teams capable of delivering robust, high-quality processes to enable the GMP testing of advanced therapies and delivery to those patients in need
  • Lead technical professionals in support of site and client objectives.
  • Establish and adhere to departmental/CBM objectives, quality, safety, and compliance standards, budgets, laboratory schedules, and program deliverables
  • Serve as lead, senior subject matter expert in advanced therapy Product and Processes, at all stages of development including analytical development, tech transfer, technical operations, GMP Testing Operations, and regulatory filings
  • Serve as Senior Leadership Team member within the analytical organization, responsible for contributing to organizational stand-up and functioning, facility readiness and maintenance, program delivery, budget setting and adherence, serving on various governance bodies, and establishing/supporting high-performing culture
  • Oversee process transfers to and from internal and external business partners
  • Support the business development function in the assessment of new opportunities and provide technical input to prospective customers, including the demonstration of capability at customer visits
  • Make decisions, based on the professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices
  • Proactively develop and sustain strong relationships with internal stakeholders in manufacturing, process development, project management, quality, etc., to promote successful customer management
  • Evaluate the functional strengths and developmental areas in the Technical Program Leaders team and drive a culture of continuous improvement
  • Own and execute Quality by Design (QbD) for programs and Analytical Control strategies
  • Provide key input into the development of manufacturing platforms and novel technologies

Qualifications

  • Solid foundation in the fundamentals of advanced therapy process and product development
  • Strong background and deep subject-matter expertise in Cell and Gene Therapy and Analytical Development
  • Working knowledge of cGMPs related to the production of microbial therapeutics
  • Process development and scale-up experience with demonstrated success in meeting process goals, tech transfer, GMP technical operations, and regulatory approvals (IND and BLA)
  • Experience in Nucleic Acid, Viral Vector, and Cell Therapy Processes including product development, cell culture, vector production, purification, and drug product processes
  • Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects
  • Rational persuasion particularly in the discussions with customers
  • Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects
  • Ability to interpret and manipulate data, define problems, establish facts, draw valid conclusions, and make decisions
  • Ability to deal with abstract and concrete variables in situations where only limited standardization exists
  • Extremely high level of initiative, agility, tenacity, and emotional intelligence
  • Excellent oral and written communication skills

Education & Experience

  • B.S./M.S./Ph.D. in biological sciences with 10+ years of experience required

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Scientist/Sr. Scientist – In-Process Analytics and Characterization

November 29, 2022

Summary

The Scientist will support the development, transfer, bridging, monitoring, and execution of analytical methods in support of cell and gene therapy process development and analytical testing. This role presents a unique opportunity within the Process Development Department to grow diverse technical and intellectual skills in a dynamic and fast-paced environment. We are seeking an individual who is motivated by our mission, is highly organized, and a team player that is flexible to support a range of projects within a fast-growing organization. The ideal candidate will be able to function independently or in a team setting, be goal oriented, organized, highly communicative, and able to contribute to several projects.

Responsibilities

  • Conduct method development, transfer, bridging, monitoring, and execution to support Process Development with robust in-process analytics and characterization.
  • Under minimum supervision develop, optimize, and execute analytical methods to evaluate cell and gene therapy products.
  • Maintain analytical instrumentation and contribute to the organization of reagent stocks, instruments, and documentation.
  • Design, execute and interpret experiments to meet objectives.
  • Develop presentations and effectively communicate technical results to internal technical groups.
  • Maintain an up-to-date lab notebook.
  • Perform and coordinate analytical testing in support of process development, manufacturing, cGMP investigations, and product characterization.
  • Collaborate with a diverse team to develop products for cell and gene therapy applications.
  • Draft technical reports to comply with good laboratory practices.
  • Generate, analyze, and record high-quality data using documentation, and database tools.
  • Participate in the support of analytical activities including method qualification, data trending, troubleshooting, optimization, review and reporting.
  • Review, interpret and communicates data cross-functionally within the organization.
  • Attend, participate in, and present results at cross-functional team meetings.
  • Author reports and source documentation to support regulatory filings.

Qualifications

  • Bachelor’s Degree in Biology, Biochemistry, Cell biology, Molecular Biology, Immunology, or related discipline with >8 years of relevant industry experience, a Master’s degree with a minimum of 3 years industry experience, or a PhD preferred.
  • Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a Process/Analytical Development laboratory environment preferred.
  • Experience developing, transferring, and executing methods required.
  • Cell and gene therapy experience preferred.
  • Prior experience with in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and other common analytics highly desired.
  • Demonstrated ability to conduct and interpret experiments to meet technical objectives
  • Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal
  • A proven ability to collaborate with team members to complete projects in an efficient and timely manner.

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Research Associate – In-Process Analytics and Characterization

Summary

The Research Associate will execute in-process analytical testing for cell and gene therapy products with a multidisciplinary Process Development team.

Responsibilities

  • Execution of testing in development laboratory
  • Collaborate with a diverse team to execute assays for cell and gene therapy applications.
  • Conduct cell-based, molecular, and analytical assays
  • With supervision design, execute and interpret experiments to meet objectives.
  • Develop presentations and communicate technical results to internal technical groups.
  • Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices. and standard operating procedures.
  • Generate, analyze, and record high-quality data using documentation, and database tools.
  • Maintain laboratory records and contribute to laboratory organization and maintenance.
  • Independently execute analytical methods to characterize viral vector and cell therapy products.
  • Perform analytical testing in support of process development, cGMP investigations and product characterization.
  • Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams.

Qualifications

  • Bachelor’s Degree in Biology, Biochemistry, Molecular Biology, Immunology or related discipline
  • Minimum 1 years’ experience in cell and molecular biology, biochemistry, chemical engineering, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
  • Minimum 1 year’s of experience with in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and/or other common analytics highly desired
  • Demonstrated ability to conduct experiments to meet technical objectives
  • Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal
  • Ability to collaborate with team members to complete projects in an efficient and timely manner.
  • Capability and desire to work in a dynamic, fast-paced, innovative environment
  • Prior exposure to GMP, ISO regulated environment is a desirable

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Associate Director/Director of In-Process Analytics and Characterization

Summary

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from concept to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

The Associate Director/Director of In-Process Analytics will be responsible for providing leadership and management over a team of analytical scientists, in support of cell and gene therapy Process Development at the Center for Breakthrough Medicines. The AD/Director will be a key member of the Process Development leadership team and will be responsible for interfacing with Analytical Development, managing method transfer and performance to Process Development, and execution of methods. The AD/Director will be responsible for building and managing a team of cell and gene therapy scientists supporting in-process and characterization methods. A key focus of this position is to ensure fit-for-purpose methods and performance to support the high demand and rapid analytics required for Process Development as it relates to titer and impurity measurements, as well as developing a strong relationship with Analytical Development to drive continuous improvement and issue resolution.

Responsibilities

  • Lead a team of highly talented scientists and associates responsible for method transfer, execution, review, and reporting for cell and gene therapy products.
  • Provides technical and scientific leadership to the team responsible for in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and other common analytics.
  • Transfer, bridge, monitor, and optimize analytical methods and support all related documentation (test methods, SOPs, protocols, reports)
  • Interface with key stakeholders including Process Development leads, Program Leadership, Analytical Development, and clients to ensure efficient and effective communication and knowledge exchange occurs as well as the establishment of necessary processes, procedures, and systems
  • Responsible for managing the professional development of direct reports, with plans for future expansion.
  • Execute on the cell and gene therapy strategy, in alignment with all CBM operations and support functions
  • Establish and monitor performance against established KPIs, internal metrics and trends to ensure the department performance against Safety, Compliance, Technical Trending and Delivery.
  • Accountable for scientific development and mentoring of scientists within reporting line
  • Fostering a culture of scientific rigor and continuous improvement
  • Ensure compliance with The Center for Breakthrough Medicines values and policies
  • Evaluate risks and opportunities with Management and drive strategic outcomes for the business.
  • Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems. Conducts employee performance appraisals in a timely and objective manner. Monitors the growth and career development of direct reports.
  • Ensure quality and assists Quality Assurance in maintaining all technical and regulatory requirements.
  • Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.
  • Represent the Company to customers, visitors, community organizations, local/state and governmental authorities, unions, industry associations and regulatory agencies.

Qualifications

  • Ph.D. in relevant field with 8+ years of cell biology laboratory experience or M.S. degree with 10+ years of relevant experience is preferred
  • Strong background and subject-matter expertise in process analytics and characterization required.
  • Experience managing a large team of full-time scientists, supporting multiple projects, and fostering a culture of innovation, teamwork, performance, and trust, with >2 years of people management experience is required.
  • >5 years of biotechnology or relevant industry experience is required.
  • Demonstrated experience transferring, bridging, training staff, and monitoring method performance.
  • Experience with cell-based functional bioassay techniques, including advanced cell culture techniques, plate-based spectrophotometer assays, ELISA, flow cytometry, RT-PCR, reporter cell lines, imaging techniques, biostatistical analysis tools.
  • Strong management/leadership skills and demonstrated ability to lead a group of scientists to deliver on objectives in defined timelines is required.
  • Independent, self-motivated, and innovative and the ability to excel in a goal-oriented, multifaceted and fast-moving team environment are required.
  • Outstanding communication, organizational and leadership skills, with a successful track record of collaborating with cross-functional scientific teams is required.
  • Capable of multi-tasking but with attention to detail, working on multiple projects, while delivering on objectives and budget

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Graphic Designer

November 28, 2022

Summary

The Center for Breakthrough Medicines is looking for a graphic designer for a full-time opportunity. We are on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a concept from idea to commercialization. Our mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

We are currently seeking a Graphic Designer who will be a pivotal member of the CBM marketing team, you will help shape how CBM comes to life across web, video, social, digital campaigns, and more. This role is integral to our ability to help grow and evolve our brand’s visual expression. You will work closely with our marketing team to drive marketing campaigns and branding efforts, as well as work on presentations for senior leaders, and customer presentations

Responsibilities

Key Responsibilities:

· Collaborate with marketing team to craft compelling stories with visuals and distill complex concepts into easy-to-understand graphics

· Partner with the team to design and produce campaigns and visual elements for web, social, events, and more

· Create and update existing marketing materials including product fact sheets, case studies (and other long form content), event design and printed material design

· Create content marketing elements including images for email banners, website, social media, landing pages and digital ads

· Support sales enablement through presentation design

· Support and maintain a visual asset library of custom graphic elements, templates for partners, photos, and more

· The senior designer possesses core skills such as:

o Expertise in layout and design and the role of typography, color, image, and visual hierarchy

o An understanding of brand identity, creation of brand systems, and application of design across all platforms

o Focus on growing our brand awareness to support strategic goals

o Agile and ready to pivot as needed

Education & Experience

· 4-7 years of graphic design experience

· BA/BFA in a design-related field or applicable work experience

· Healthcare or Pharma experience in a B2B environment a plus

· Deep graphic design knowledge and awareness of design trends

· Strong interpersonal written and verbal communication skills, along with presentation skills

· Strong attention to details and organization, including the ability to prioritize tasks, communicate progress, and meet deadlines

· Detailed, expert knowledge of Adobe design programs (Photoshop, InDesign, Illustrator, XD, Premier, etc.)

· Expertise in designing for both digital/mobile and print mediums

· Strategic thinker willing to challenge conventional wisdom and eager to reinvent modern marketing tactics

· Ability to multi-task and own multiple projects at once

· Strong attention to detail

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Associate Director, Events Marketing

November 23, 2022

Summary

Events Marketing, Associate Director

The Center for Breakthrough Medicines (CBM) is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization (CDMO) in the world. CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies. CBM is located just outside of Philadelphia in the Heart of Cellicon Valley; set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

This leader is focused on CBM’s event program ranging from the industry’s largest user group and industry events to global sales and employee meetings and conferences. A visionary, this team leader owns the strategy, content, and implementation of exciting, engaging, and flawless experiences, directing a team of in-house digital and event experts. This highly visible role offers a unique opportunity to reimagine and architect the company’s go-to-market strategy for events that are focused on brand expansion and demand generation across a spectrum of virtual and live venues.

This critical team member will come in with fresh ideas and new thinking, including using emerging technologies and platforms to drive business results while creating amazing experiences. It works closely with marketing executives and eco-system partners to create and align programs with company strategy and program goals. A passion for technology, digital marketing, and a data-driven mindset is part of the skillset of this key executive.

Responsibilities

  • Collaborate closely with marketing leadership and cross- audience teams to identify opportunities for brand activations and sponsorships that align with marketing key priorities
  • Identify industry tradeshows and company hosted events that will drive customer engagement and brand promotion
  • Manage vendor relationships to ensure event needs are met
  • Collaborate with key stakeholders to determine the audience event strategy, goals and objectives for each event
  • Recommend tactics to support goals, measure and report on the success of each event
  • Curate and execute impactful customer experiences
  • Lead the selection of venues, budgeting, securing sponsorships, handling logistics, handling event marketing, negotiating with sub-contractors and evaluating event effectiveness that drives sales and generate awareness
  • Drive stakeholder conversations to gain alignment
  • Manage day-to-day operations of the global marketing events calendar and mange budget tracking for assigned events
  • Collaborate closely with cross audience stakeholders to identify brand event KPIs, metrics, and create reporting dashboards for marketing, sales, and medical leadership
  • Recommend process improvement initiatives to help streamline and optimize the event planning and evaluation process globally
  • Ensure excellent customer service and superior customer event experience
  • Shape and lead the event’s vision, including content strategy and plan, and be accountable for success metrics
  • Oversee event manager as they execute comprehensive events programs
  • Create event marketing plans and provide ongoing reporting against registration, attendees, and overall goals
  • Collaborate across the organization to ensure consistent alignment and transparency of event goals and strategies
  • Be the subject matter expert on event trends and recommend new event opportunities and monitor competitor event activity
  • Oversee all pre-event and post-event communications and marketing initiatives
  • Manage vendor relations and ensure compliance with corporate rules and guidelines

Qualifications

  • Bachelor’s degree (business, marketing, communications is highly preferred)
  • 7+ years of experience in event strategy, planning and execution, preferably in pharma services industry
  • Experience in planning a diverse portfolio of events
  • Experience in planning events in EU, UK and APAC a plus
  • Experience in identifying and building event KPIs, metrics and ROI reporting highly preferred
  • Ability to travel domestically and internationally (upto 30%)
  • Strong written and verbal communication skills, strong business acumen, able to effectively negotiate
  • Strong Excel and PPT skills
  • Strong communicator and influencer

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Director, Proposals

Summary

The Center for Breakthrough Medicines at The Discovery Labs is currently searching for a Director, Proposals to join our team full-time. This is an excellent opportunity to join a developing team with a clear path for growth. The Director, Proposals will work within the Business Development Proposals group to lead development of responses to our clients’ Requests for Proposals (RFP) and/or Requests for Information (RFI) in support of development and manufacturing programs in the cell and gene therapy space. The creation of proposals and responses to RFIs includes the gathering and coordination of input from multiple groups within CBM, such as Process Development and Technology Transfer, Analytical Development and Testing, Manufacturing, Quality, and Regulatory, and writing the response from source documentation. Work also includes leading development of costing models, process plans and statements of work. In addition, this individual will be responsible for leading change order (CO) management within the Proposals group and creation of standard proposal/CO templates/tools and a standardized proposal/CO generation process.

This position offers opportunity for growth within the Business Development organization, including involvement with and execution of marketing strategy, technical conference attendance, performance of competitive and industry analyses, and general client-facing representation for the business.

Responsibilities

  • Oversee all aspects of proposal development, initially with a focus on viral vector and plasmid modalities, including coordination cross-functionally to obtain technical, budget and schedule information, writing and/or editing proposal language and pricing models to deliver cohesive, compelling proposals to potential clients
  • Perform quality check of all proposal content, to include checking for RFP compliance and adherence to proposal standards to ensure accuracy and quality of work.
  • Responsible for CO management within the Proposals group, including establishing templates/tools and process development, planning/prioritizing, making assignments and providing guidance to proposal leads as well as development and review of COs
  • Work with Proposal and Business Development leadership to support strategic proposal initiatives including developing/implementing updated processes and establishing tools/templates/databases to standardize development of cohesive, consistent proposals across the organization.
  • Work with Proposal leadership and the finance team to evaluate financial performance of executed programs in comparison with previously scoped work to establish a continuous feedback loop to optimize pricing models.
  • Lead process improvement initiatives based on lessons learned from existing projects to increase efficiency, effectiveness and success of future projects
  • Contribute to team and departmental initiatives outside of day-to-day BD/proposal activities

Qualifications

  • Bachelors Degree in a relevant scientific discipline or business related field Engineering). Candidates with non-scientific degrees will be considered with relevant experience in the Life Sciences industry.
  • 8+ years combined technical and proposal writing experience in the Life Sciences Industry.
  • Candidates must have experience generating proposals in the Life Sciences industry. Any experience supporting specific proposals concerning cell and gene therapies, biologics, or experience within the CDMO space is a major plus.
  • Ability to comprehend and edit/incorporate information and data across multiple aspects of Cell and Gene Therapy Development and Manufacturing (process development, analytical development, technology transfer, testing, clinical and commercial manufacturing, regulatory support)
  • Proficiency with Acrobat, and Microsoft Office Suite (particularly Word, Outlook, Project, and Power Point, Teams with Advanced Proficiency in Excel); and the ability to proficiently use company business system software (Salesforce).
  • Broad technical knowledge in Life Sciences or biologics manufacturing and understanding of business as well as best-practice proposal development processes.
  • Communication, tact, and interpersonal skills to work with all levels of staff and leadership, within and outside the department and Company; ability to work with a diverse team, including managers and peers.
  • Ability to lead a team and work with minimal supervision.
  • Complex reasoning and problem-solving abilities.
  • Detail oriented; strong analytical and writing skills; meticulous attention to detail.
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Proposal Associate

November 22, 2022

Summary

The Center for Breakthrough Medicines at The Discovery Labs is currently searching for a Proposal Associate, Analytical Services to join our team full-time. This is an excellent opportunity to join a developing team with a clear path for growth. The Proposal Associate, Analytical Services will work within the Business Development Proposals group to develop responses to our clients’ Requests for Proposals (RFP) and/or Requests for Information (RFI) in support of Analytical Development and Testing programs in the cell and gene therapy space. The creation of proposals and responses to RFIs includes the gathering and coordination of input from multiple groups within CBM, such as Process Development and Technology Transfer, Analytical Development and Testing, Manufacturing, Quality, and Regulatory, and writing the response from source documentation. Work also includes assistance in development of costing models, process plans, statements of work, executive summaries, and slide decks. In addition, this individual will be responsible for working with Business Development to create standard proposal templates and creation of a standardized proposal generation process.

This position offers significant opportunity for growth within the Business Development organization, including involvement with and execution of marketing strategy, technical conference attendance, performance of competitive and industry analyses, and general client-facing representation for the business.

Responsibilities

  • Review Analytical Services RFPs and RFIs and work with Business Development and technical staff to understand technical scope and proposal requirements.
  • Work with Business Development to create Analytical Services proposal process to include pricing templates, proposal templates, information management standards, and establishment of the Analytical proposal review and approval process within the organization.
  • Write and manage development of new proposal material and revise existing proposal materials based on new requirements in collaboration with Management and other leaders within the organization.
  • Work with Business Development leaders and Finance staff to evaluate executed programs in comparison with previously scoped work to establish a continuous feedback loop to optimize pricing models.
  • Perform quality check of all proposal content, to include checking for RFP compliance, basic proofreading, and adherence to other proposal standards to ensure accuracy and quality of work. Ensure proposal materials are edited appropriately as part of the proposal process.
  • Establish and maintain an organized file structure in CBM’s MS Teams site.
  • Maintain accurate records in CBM’s Salesforce system
  • Perform other duties and lead special projects as required and assigned

Qualifications

  • Bachelors Degree in a relevant scientific discipline required (i.e., Biology, Biochemistry, Biomedical Engineering). Candidates with non-scientific degrees will be considered with relevant experience in the Life Sciences industry.
  • Minimum 2-4 years combined technical and proposal writing experience in the Life Sciences Industry preferred.
  • Candidates must have experience generating proposals in the Life Sciences industry. Any experience supporting specific proposals concerning cell and gene therapies, biologics, or experience within the CDMO space is a major plus.
  • Strong technical understanding of analytical services including analytical development, transfer, verification, optimization, qualification, and validation. Knowledge of the technical requirements to support routine testing and stability programs.
  • Proficiency with Acrobat, and Microsoft Office Suite (particularly Word, Outlook, Project, and Power Point, Teams with Advanced Proficiency in Excel); and the ability to learn and proficiently use company business system software.
  • Broad technical knowledge in Life Sciences or biologics manufacturing and understanding of business as well as best-practice proposal development processes.
  • Ability to author proposal sections/documents with input from technical teams, as well as work with Finance to generate reports.
  • Communication, tact, and interpersonal skills to work with all levels of staff and leadership, within and outside the department and Company; ability to work with a diverse team, including managers and peers.
  • Ability to work with minimal supervision.
  • Complex reasoning and problem-solving abilities.
  • Detail oriented; strong analytical and writing skills; meticulous attention to detail.
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Warehouse Associate

November 14, 2022

Summary

Center for Breakthrough Medicines is seeking a Warehouse Associate to perform a variety of warehouse operations, including receiving, put-away, inventory management and material movement.

The Warehouse Associate collaborates and communicates with warehouse personnel, logistics technicians, customer service representatives, service providers, and others involved in the shipment and receipt of products. S/He also keeps updated logs by tracking, tracing, and updating the status of incoming and outgoing shipments.

Responsibilities

  • Perform the daily warehouse activities to meet the demands of clinical and commercial manufacturing in a timely manner to ensure no delays in supply chain
  • Move equipment from warehouses to campus
  • Manage the shipment and receipt of all products, materials, and supplies.
  • Track, trace, and update the status of incoming and outgoing shipments.
  • Maintain a clean, neat, and member-ready area.
  • Promptly unload trucks and deliveries.
  • Sort and stock receivables.
  • Scan and sort incoming and outgoing stock
  • Work with external vendors, couriers, custom agents to facilitate shipments
  • Communicate necessary information internally and externally as required. Work across internal functions to communicate the timelines to prevent any delays
  • Comply and adhere to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Import/Export Practices for all activities Ensure efficient daily operations of the warehouse team
  • Demonstrate an understanding of the company quality policy
  • Communicate well with leadership, team members and other departments

Qualifications

  • High School Diploma, GED, or equivalent
  • 6 months logistics, retail, or customer service experience
  • Good written and verbal communication skills
  • Strong sense of time organization and urgency
  • Able to work independently and within a team

Physical Demands

Lift up to 70lbs

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