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Manufacturing Support Services Lead Associate

Summary

The Manufacturing Support Services Lead Associate will serve as a role model to lead a diverse team towards achieving on-time delivery of manufacturing support by performing routine cGMP cleaning, assembling, transfer, and decontamination activities that aid in gene therapy production. The incumbent will embrace and promote right-first-time culture by supporting the manufacture of viral vectors, non-viral vectors, and advanced therapeutics while maintaining compliance to cGMP standards.

We are looking for individuals that have experience as a goal and solution-oriented team player, are hard-working, highly motivated, and eager to contribute to building a manufacturing operation. The individual will also have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team and show commitment to the highest safety and quality standards. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a supervisor role.

Responsibilities

  • Work in a hands-on capacity to prepare buffers, assemble jumper harnesses, and clean/sterilize equipment and materials.
  • Work closely with manufacturing personnel by transferring/stocking critical materials and delivering samples throughout the facility.
  • Clean GMP spaces, collect waste from production suites, and perform decontamination protocols.
  • Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Proactively assist in the resolution of manufacturing support deviations/non-conformances and troubleshooting of support process and equipment problems.
  • Lead and motivate operational staff by promoting a culture of inclusiveness, safety, continuous improvement, training objectives, and compliance.
  • Provides timely technical input, when necessary, to support ongoing operations.
  • Assist with on-the-floor review of batch records in real time.
  • Assist in the development of training material to support the initial and ongoing training of manufacturing support personnel.
  • Identify opportunities for improvements in process, safety, quality, and cost.
  • Lead training of new manufacturing support associates.
  • Leads initiative to assist in validation activities related to the qualification of the manufacturing support process, facility suites, and equipment.
  • Acts as qualified trainer for SOPs and procedures in functional area.
  • Verify inventory and escalate to supervisor when supplies are low.

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 4-6 years of experience in cGMP biological manufacturing. Contract, Development, and Manufacturing Organization (CDMO) experience preferred.
  • A minimum of 1-3 years of leadership experience.
  • Advanced experience working with autoclaves, washers, aseptic operations, and cleanroom decontamination procedures is highly preferred.
  • Advanced knowledge of cGMP regulations.
  • Proven ability to troubleshoot and resolve equipment and processing issues.
  • Advanced efficiency working in a Biological Safety Cabinet (BSC).
  • Demonstrated ability working with pipettes, micropipettes, and scales.
  • Demonstrated experience working with decontamination practices for materials and liquids.
  • Demonstrated experience handling and formulating cleaning solutions.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits extreme attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows eagerness to learn and problem-solve.
  • Innovative and efficient when solving problems with a strong focus on continuous improvement.
  • Possesses sound technical aptitude to learn and operate production equipment.
  • Ability to teach, lead and mentor co-workers.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Able to accommodate a flexible work schedule to support business demands.
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.
August 10, 2022

Sr. Operations Engineer, Nucleic Acids and Plasmid Operations

Summary

The Sr. Operations Engineer will play a key, hands on, cross-functional role in translating process design to operational execution.Planning, scheduling, and the coordination of direct and supporting activities to ensure a successful operation will be required. This role will facilitate operational coordination across and collaboration with internal and external key stakeholders to drive results, deliverables, and timelines for internal projects and initiatives. This role will support effective implementation of policies, best business practices, and processes, and procedures.

In addition to operational standup and execution, this position will mange the establishment and improvement of operational metrics via continuous improvement.This will include oversight of cross-functional workstream including but not limited to Process Development, Quality, Procurement, Finance, and Facilities/Engineering. This is a critical role with oversight for the implementation of operational excellence strategies to optimize operational efficiencies with a data-informed and metrics-based approach. This position will influence strategy execution based on the data reporting, KPI management, and process redesign and improvement

Responsibilities

·Provides operational coordination across a cross-functional team for internal projects in laboratory services, supply chain, quality, IT, facilities and engineering, and client project management

·Collaborates with internal and external key stakeholders to drive results, timelines, and deliverables for a portfolio of projects and initiatives within budget

·Supports the efficiency of existing processes and procedures to enhance and sustain internal capacity

·Ensures timely and effective communications within the business unit

·Executes against an operational process design and reports back opportunities, challenges, and gaps

·Supports change management and continuous improvement efforts

·Helps monitor, and interpret operational metrics to drive efficiency and improvement projects

·Participates in interpretation, analysis, and actionable improvements

·Adheres to cGMP compliance and leads efforts to seamlessly integrate compliance into business processes

·Contributes to and supports technical writing efforts, including but not limited to drafting, editing, and improving SOPs that meet both compliance requirements and foster best business practices

·Helps foster a high performing cross-functional, matrixed team through collaboration, communication, time management, and accountability

·Build and maintain data collection, management, and reporting systems across cross-functional systems

·Manage metrics, dashboard, and scorecard reporting

·Diagnose and drive data-based improvements across processes through data analysis, Gemba walks, process monitoring, and employee interviews

·Work with leadership to develop tactical implementation plans across workstreams

·Work with leadership to plan and build capacity and capability, identify operational efficiencies, cost savings, and reduce process waste

·Work with training and leadership teams to execute on operational excellence capabilities for testing teams

Help set up and manage robust and effective communication systems

Education & Experience

·Bachelor’s degree in science or engineering required. Master’s in science or engineering preferred

·5+ years of cross-functional experience in biotechnology with a strong understanding of operational excel, continuous improvement, Lean Six Sigma and project management is preferred

·Lean Six Sigma Certification preferred

·Excellent data analysis, reporting, and organizational skills

·Independent thinker with a track record of working collaboratively in a matrixed environment to achieve goals

·Highly functioning, process-oriented, and self-starter mind-set required

·Experience with cGMP, ISO regulated environment is required

·Excellent attention to detail with strong documentation, communication, and data presentation skills

·Must be able to thrive in a fast-paced, startup environment with tight deadlines

August 9, 2022

Associate Director, Plasmid/Nucleic Acids, Process Development

Summary

This role is responsible for leading and overseeing mRNA and plasmid operations including in vitro transcription, microbial fermentation and purification process development. The position has responsibility for technical product lifecycle management in the nucleic acids asset pipeline.The ideal candidate will help design and startup a nucleic acid process development laboratory to support plasmid DNA production and mRNA synthesis. The ideal candidate will lead the process development and scaleup mRNA, plasmid DNA, and other nucleic acid assets. Experience in Microbial Fermentation Upstream and/or Purification Process development and optimization is a requirement. This position works closely with internal and external stakeholders to deliver technical documents such as reports, protocol, and data reviews. During the clinical/commercial manufacturing preparation phase, this role will serve as a senior leader for the delivery of key product development and tech transfer deliverables.

The primary responsibility of this candidate is to develop a scalable end to end plasmid production platform, support technical transfer/scale-up activities, and troubleshoot technical nucleic acid production. The scientist will also collaborate with both external and internal stakeholders to support ancillary activities such as analytical testing, cell banking, process scaleup, and technical transfer.In addition to the technical skills required, this role will be held accountable for technical protocols, reports, batch records and SOPs. The ideal candidate will successfully demonstrate upstream and downstream process development, scaleup, and analytics. Personal attributes including independent thinking, having a self-starter mindset, and strong collaboration skills are required. This leadership role will defined the process development strategy for nucleic acids, and previous management experience is preferred.The final level of this position will be set according to candidate experience and qualifications.

Responsibilities

·Designs and implements microbial strategies for upstream and downstream process development

·Experience in developing, executing, and optimizing of upstream (fermentation, scale-up, characterization) and downstream (centrifugation, chromatography, and tangential flow filtration) unit operations

·Leads process development studies and reviews technical data and documentation

·Supports technology transfer into GMP manufacturing

·Works closely with internal/external partners on appropriate process and characterization studies to enable manufacturing

·Assists with product quality attribute assessment and scoring to identify critical quality attributes (CQA)

·Build, hire and develop a team of PhD & non-PhD staff that has the capability to design, plan, and execute experiments to develop and understand processes for production of plasmids

·Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit

·Independently review the design, execution, data and reporting on the development work completed within the Process Development group. Is expected to resolve (or have resolved) all technical issues

·Provides key input into the development of manufacturing platforms and novel technologies

·Leads both direct and indirect sub-teams

Qualifications

·PhD in chemical engineering, microbiology, biochemistry, biotechnology, biology, or related field with 6+ years of industry-related experience; or M.S. with 8+ years; or BS with 10+ years of related industry experience

·Ability to lead a cross-functional team to deliver on programs. Previous management experience is required

·Experience in plasmid, mRNA, and/or ASO nucleic acid processes and technologies

·Experience in molecular biology, plasmid design and elements, and manufacturing processes, specifically, transformation, cell banking, production, purification, and storage

·Knowledge and experience in QbD and cGMP is preferred.

·Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects

·Strategic leadership and conceptual thinking to ensure that a cost-effective organization is put in place and developed

·Project-management skills and ability to work successfully with contracting laboratories and manufacturing facilities

·Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

·Demonstrated ability to maintain detailed execution records and perform data analysis

·Expertise in microbial upstream and downstream process development, such as large-scale (50L) fermentation, depth filtration, tangential flow filtration, chromatography column purification

·Experience with microbial production, purification, and characterization

·Strong communication skills (e.g., clear and concise) and a team player

·Strong time and project management skills

·Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution

·Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment

·Takes ownership of the assigned project, consulting with management and peers

·Able to understand and interpret data/information and its practical application

Biomaterials Scientist/Engineer II

Summary

The Biomaterials Scientist/Engineer is a member of Materials Science and responsible for assisting in providing knowledge and expertise to ensure that materials performance is aligned with the specific intentions of the user, the regulations that dictate GMP practices and patient safety.This individual will assist in providing materials integrity, accuracy, and consistency across the CBM organizations that are involved in the use and transformation of materials in processes, as a drug product or in contact with the drug product, as raw and ancillary materials and intermediates or in materials selection, specification and source.

This individual will serve on multidisciplinary teams to affect the flow of materials and materials information from client to release for manufacturing.You will contribute to the definition, creation and defense of new materials specifications and participate in the investigation and vetting of their suppliers and manufacturers.You will provide materials expertise to internal organizations that require assistance in materials selection and compatibility.

Responsibilities

The biomaterials scientist/engineer will contribute to the development of a hybrid internal and external extractables and leachables (E&Ls) evaluation and testing program.You will be involved in all aspects of product and process development, tech transfer where biomaterials are involves and will be expected to apply your skills and knowledge more broadly across other CBM business units as required.You will review and author technical reports and the open literature to remain cognizant on current trends especially in C&GT and single use systems.You will author / contribute to risk assessments involving particulates and E&Ls and other aspects of materials science and engineering as required.

  • Responsibility focus:cell & gene therapy reagents and systems materials – materials of biological and non-biological origin,
  • Work in project teams to usher new materials through for use in GMP manufacturing insuring they are properly specified, characterized and aligned with their intended use.
  • Evaluate, codify and amass knowledge of all aspects of materials attributes, origin, use, storage, contact issues, viability, testing, knowledge of process use, biological functioning.
  • Establish C&GT knowledge of process (KoP) / materials relationships and serve as SME to members of materials science and other organizations as needed.
  • Provide or develop CBM-relevant expertise in biosurface stability and dynamics, particulate generation, extractables and leachables,
  • Develop predictive capabilities to streamline evaluation of complex processes and products
  • Work with other material science members to develop predictive materials behavior tools to aid in the evaluation of complex assemblies or configurations where absence or difficulty in acquiring empirical data exists.
  • Contribute to the evaluation of material, material supplier & manufacturer, sampling and testing plans of critical biomaterials and attributes.
  • Where necessary obtain empirical data or perform tests or arrange for internal or external testing of materials to ensure functionality, performance and compatibility.
  • Support transfer of knowledge among CBM organizations.
  • Provide direct support to drug product and drug process development systems, support multiple projects at different stages of development.
  • Serve as a the Materials Science core team member for client sponsored programs.
  • Contribute to the overall smooth flow of materials and materials information throughout the CBM.

Education & Experience

Education

  • Advanced degree (MS or Ph.D.) or equivalent experience in biomaterials, biology, materials science or engineering or relevant area of scientific research
  • Strong written and oral communication skills
  • Experience with cell and gene therapy and or biopharm materials and products
  • Experience with materials characterization and analytical instrumentation
  • Microsoft Excel expertise and proficient in the MS Office / Windows environment

The following experiences are a plus:

  • Experience working in a burgeoning entrepreneurial environment
  • Knowledge of the USP, and Eu. Ph., Jp. Ph., …, ISO standards
  • Experience with extractables & leachables, biocompatibility, toxicological and particulate assessment (ISO 10993)
  • Knowledge of materials modeling and properties computation
  • Analysisand interpretation of data, with use of data analysis tools (JMP, Minitab, … )

Materials Data Scientist/Engineer

Summary

The Materials Data Scientist/Engineer is a member of Materials Science and responsible for assisting in providing knowledge and expertise to ensure that materials performance is aligned with the specific intentions of the user, the regulations that dictate GMP practices and patient safety.This individual will assist in providing materials integrity, accuracy, and consistency across the CBM organizations that are involved in the use and transformation of materials in processes, as a drug product or in contact with the drug product, as raw and ancillary materials and intermediates or in materials selection, specification and source.

This individual will serve on multidisciplinary teams to affect the flow of materials and materials information from client to release for manufacturing.You will contribute to the definition, creation and defense of new materials specifications and participate in the investigation and vetting of their suppliers and manufacturers.You will provide materials data expertise to internal organizations that require assistance in materials selection and compatibility.

The Materials Data Scientist/Engineer will support the raw materials program at the CBM. The individual will be a key member of the materials science team supporting materials data flow throughout the CBM.You will work with members of Process Development, Program Management, Information Technology, Testing and Analytical Services and Quality Control and Regulatory business units.

Responsibilities

Primary duties include but are not limited to:

  • Supporting the preparation and review of raw materials data, including specifications, testing plans and risk assessments, for the manufacture of C&GT products.
  • Compiling data for the specification, testing and sampling of raw materials.
  • Contributing supplier and manufacturer database development for raw materials and consumables.
  • Participate in the writing and revise SOPs as it pertains to materials information data.
  • Contribute data to protocols and reports for raw material qualification.
  • Contribute to creation of routines for the flow of materials data from sources to end users.
  • Review manufacturers’ and suppliers’ product specification data and certificates of compliance and analysis for consistency and the materials attributes needed for materials intended uses
  • Contribute to the writing and revisioning of SOPs as it pertains to data specifying, acceptance, testing strategy and disposition of raw materials

Education & Experience

Required Qualifications:

  • Minimum of bachelor’s degree in technical field with preference in chemistry, materials, biological/biopharm science, pharmacy
  • Knowledge of in materials/chemical name discrimination and identification
  • Knowledge of materials qualities and discernment of test for their attributes
  • Ability to author and review protocols, reports, and standard operating procedures
  • High level experience and proficiency with Microsoft Excel and data maintenance
  • Good written, verbal, and interpersonal skills to effectively interact with cross-functional teams.
  • Ability to manage multiple priorities and tasks in a dynamic environment
  • Ability to work in a team environment or independently with minimum supervision on day-to-day activities

Desirable Qualifications:

  • Experience with material specification and testing with preference in GMP environment.
  • Experience with FDA/GMP regulations with preference of USP, EP and ICH Guidelines.
  • Experience with compendial reviews for new and/or revised compendial requirements.
  • Experience in preparation of raw material specification documents and certificate of analysis.
  • Very high level of Microsoft Excel proficiency
  • Experience with SAP system.
  • 1 to 3 years working in GMP environment.

Warehouse Associate – TEMP

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
  • 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

Associate Director, Validation

Summary

The Associate Director of QA Validation will be responsible for. providing leadership and strategic direction to the establishment of the validation/qualification programs (including the Qualification/PM/Calibration of instruments and equipment, as well as building and facility commissioning and qualification), ensuring alignment with industry standards and regulatory guidances. The QA Validation Associate Director will support the execution of validation and qualification protocols and reports as they apply to facilities, utilities, equipment, computer systems, cleaning and processes. Additionally, the Associate Director of QA Validation will be responsible for the support of facility start-up activities, technical transfers, re-qualifications and routine activities as they pertain to Laboratories, Manufacturing, facilities, Maintenance and Warehouse functions

Responsibilities

·Manage the validation program from a Quality Assurance perspective to ensure quality and compliance requirements are met in an efficient and effective manner, in support of corporate objectives.

·Act as the quality/ validation expert supporting GMPsystems and compliance to industry regulations

·Ensure required Standard Operating Procedures and systems are implemented to support internal and external validation programs.

·Provide quality oversight and approval of software, equipment/facility qualification.

·Ensure Site Validation Master Plan is followed at site level.

·Provide guidance , oversight and approval of internal and external method qualification, method transfer and method validation project plans, protocols and reports.

·Provide leadership and guidance to staff on qualification/validation matters and compliance to industry regulations: 21 CFR Parts 11, 211, 820, 1271, 600, EU Guidance for Advanced Therapies and Medicinal Products, EU Annex’s, GAMP5 and other industry standards as applicable

·Review and revise SOPs for consistency and compliance with regulatory requirements

·Support regulatory inspections by FDA and foreign regulatory agencies

·Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met.

·Actively seek out new, cutting edge technology to further Quality Operations initiatives and build efficiencies.

·Participate in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.

·Lead standardization and harmonization of Standard Operating Procedures.

·Partner with Research and Development and Tech Transfer groups to develop and execute product technical transfer plans to manufacturing facilities.

·Provide support to the initiation, assessment and implementation of internal change controls.

·Apply risk based methodologies in the oversight of validation efforts.

·Provide guidance and direction throughout the Change Control process supporting GxP Systems.

·Participate in cross-functional risk assessments and process parameter classification

·Provide hands-on review and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports.

·Participate in interdepartmental project/program teams to meet site objectives.

·Provide expertise to technical teams in the implementation of strategies for validation studies.

Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction

Qualifications

·Bachelor’s Degree in science or technical discipline

·A minimum of eight (8) years’ experience in Quality Assurance in the Pharmaceutical, Biotech (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing. (Advanced degrees may be used to reduce required experience.)

August 2, 2022

Director of QA Manufacturing Operations, Cell Therapy

Summary

The Center for Breakthrough Medicines is looking for a quality expert to support the organization by establishing quality operational processes, quality systems, driving growth, and ensuring quality across cell therapy manufacturing operations. The Director of QA Manufacturing Operations will be responsible for the overall management of quality operations, audit readiness, data integrity, and document control supporting Cell Therapy product release for client services.This role will provide leadership, strategic thinking, and results focus mindset to reliably meet and/or exceed the site’s performance targets and client demands while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced environment and deliver exceptional service to our clients.

Responsibilities

·Direct and oversee all aspects of QA manufacturing operations within the organization, including but not limited to batch record review, QA support on floor, material release, deviation investigations, CAPAs, change controls, customer quality support, SOPs.

·Foster a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.

·Manage problems of varied scope using a high degree of prudence and risk-based decision making.

·Develop, motivate, and lead teams of cross-functional resources in a matrixed organization with competing priorities.

·Interpret industry regulations and guidance documents for the creation and implementation of quality standards, quality operational procedures andpolicies, and site procedures

·Partner with other business units or departments in support of continuous improvement initiatives.

·Author or revise SOPs to address gaps or necessary improvements to Quality Systems.

·Develop and provide cGMP and other GxP training as needed.

·Maintain knowledge of global regulatory requirements for the Cell and Gene Therapy products.

·Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance.

·Develop and maintain systems that insure the technical and regulatory competency of personnel within the organization.

·Interact with the quality team and internal stakeholders to support the development, manufacturing, manufacturing, packaging and release of manufacturing products as needed.

·Additional duties as assigned.

Qualifications

·Solid understanding of industry regulation 21CFR 210, 211, 11, 820 as well as EU Guideline for Advanced Therapy and Medicinal Products.

·Significant experience with both digital and paper based QMS solutions.

·Diverse Quality operations experience across functions in GMP including CRO/CDMO oversight activities.

·Regulatory experience a plus.

·Bachelor’ s Degree in a commercial or scientific field required, advanced degree MS, PhD or MBA preferred.

·Minimum of 10-15 years of progressive managerial experience within biopharmaceutical Quality Assurance.Cell and Gene Therapy industry experience is a plus.

·10 years’ in-depth experience in GMP/GXP industry.

·In-depth knowledge of risk management systems and/or computer systems validation programs strongly preferred e.g., Veeva, Labware (LIMS), SAP

·Previous experience preparing for and leading client audits and/or regulatory inspections.

·Judgment and problem-solving – able to define decision criteria and determine the most appropriate course of action.

·Planning and organizational skills – able to establish objectives and schedule tasks and resources efficiently.

·Communication skills – strong written communication skills to provide concise and clear documentation.

·Partner with other business units or departments in support of continuous improvement initiatives.

·A hands-on leader who can perform day-to-day QA activities as well as direct others to perform such work.

·Excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management.

·Ability to provide solution minded approach and flexibility to emerging challenges.

·Able to appropriately balance priorities plus multitask against competing priorities.

·Certifications is an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma

·Knowledge of tools, concepts and methodologies of QA

·Solid experience in effective usage of data analysis tools and statistical analysis

·Proficient in Microsoft Office (Excel, Word, Outlook).

August 1, 2022

Payroll Manager

Summary

The Payroll Manager will oversee and supervise the organization’s payroll functions, ensuring pay is processed on time, accurately, and in compliance with government regulations.

Responsibilities

·Implements, maintains, and reviews payroll processing systems to ensure timely and accurate processing of payroll transactions including salaries, benefits, garnishments, taxes, and other deductions.

·Ensures accurate and timely processing of payroll updates including new hires, terminations, and changes to pay rates.

·Prepares and maintains accurate records and reports of payroll transactions.

·Ensures compliance with federal, state, and local payroll, wage, and hour laws and best practices.

·Leads year end processing of W-2s and related tax adjustments and filings.

·Administers 401(k) plan, including processing of contributions and coordination of 5500 filing.

·Reviews and processes employee expense reports.

·Facilitates audits by providing records and documentation to auditors.

·Identifies and recommends updates to payroll processing software, systems, and procedures.

·Assists business units with enforcement of hours tracking guidelines.

·Calculates labor allocations for accounting based on hours tracking.

·Calculates labor, bonus, and other payroll-related accruals on a monthly basis.

·Performs other duties as assigned.

Qualifications

·Extensive knowledge of the payroll function including preparation, balancing, internal control, and payroll taxes.

·Excellent organizational skills and attention to detail.

·Strong analytical and problem-solving skills.

·Strong leadership skills.

·Proficient with Microsoft Office Suite or related software.

·Proficient with payroll software.

·Ability to support and adapt to new or changing systems and integrations.

Education & Experience

·Bachelor’s degree in Accounting, Business Administration, Human Resources, or related field required.

·Three to five years of related experience required.

Physical Demands

·Prolonged periods of working at a desk and computer.

·Must be able to lift 15 pounds at times.

July 29, 2022

Sr. Product Marketing Manager

Summary

The Sr. Product Marketing Manager role will lead garnering deep customer insights, building market segmentation, developing product and portfolio positioning, crafting market development strategies, defining tactics and content, ensuring operational readiness, and sustaining market growth. This individual will ideate and deliver brand and product campaign strategies, marketing materials, messaging, identify target customer relationships, website content, and various other projects/programs directly promoting CBM products. This individual will cross-functionally work with multiple business units, the commercial team, and other functions to develop and launch differentiated product offerings and solutions to cell and gene innovator companies. The Sr. Product Marketing Manager works well in a fast-paced environment, is organized and able to dynamically prioritize between short-term asks and long-term business needs.

Responsibilities

  • Strategically partner with business unit leaders to understand market needs and translate into differentiated solutions
  • Create clear, effective, and integrated strategies, plans, and tactics for current and new product launches, such as content development, customer engagement, customer experience, and lead generation.
  • Analyze and incorporate key market and clinical trends, customer needs and segmentation, disease state insights, and competitive offerings for the development of the product’s commercialization strategy.
  • Support the tactical execution of select marketing initiatives delivering against predefined strategies to achieve product and business objectives and goals.
  • Lead the development and execution of promotional materials and programs directed at key customers with an eye towards driving awareness and education.
  • Develop deep insight into the buyer personas for your BUs, the buyer journey, and use this insight to help guide messaging and content creation.
  • Work with subject-matter experts (SMEs) within your BU to create and maintain marketing and sales assets that appropriately target buyers throughout their journey. Assets include positioning/sales guides, sales playbooks, case studies, whitepapers, eBooks, product demonstrations, infographics and more

Qualifications

  • Big picture thinker who can identify solutions to meet evolving Business Unit and enterprise priorities.
  • Passionate, results-oriented, and driven by collaborative outcomes.
  • Positive and resilient in the face of change and challenge.
  • Flexible to new methods, approaches – comfortable pivoting to meet the moment.
  • Organized and polished with excellent executive presence.
  • Strong writing abilities, presentation skills, and stakeholder management.
  • Excellent communication and presentation skills, including the ability to engage with cross-functional team members at all levels of the organization.
  • Familiar with marketing automation tools such as Hubspot, and Google Analytics.
  • Strong problem-solving skills and willingness to roll up one’s sleeves to get the job done.

Education & Experience

  • Bachelor’s Degree in Life Sciences, Business or Marketing.
  • 8+ years of professional work experience in life science, biopharma, CDMO’s (cell and gene therapy a plus)
  • Demonstrated ability to successfully launch and market products in a highly competitive market.
  • Previous experience analyzing client needs, setting and managing expectations, and influencing decisions.
  • Ability to thrive in a fast-paced environment with multiple competing priorities.