- The person in this position will assure that commercial bulk drug substance (BDS) manufacturing processes in the Company's supply chain (internal or external) for production of biologics (monoclonal antibodies and proteins) and any antibody drug conjugate (ADC) based products are robust, scalable, well controlled and capable of providing the highest quality product to patients within this human health care pharmaceutical company.
- The complexity of the BDS manufacturing process and potential impacts on product quality attributes is greater for biologics than for traditional small molecule production.
- This position is accountable for assuring the Company's success in commercializing BDS manufacturing for current late stage development pipeline (KANAb-001, MORAb-003) and future biologics ADC products in development (MORAb-202, etc.) by providing direct, daily technical support to MDC/PST/Exton operations.
- The position will also be accountable for technical oversight and support for CMOs used to produce BDS, technology transfers (when applicable) and technical life-cycle management of the BDS manufacturing activities after approval.
- Applies knowledge and knowhow related to upstream and downstream commercial BDS manufacturing operations to manage and troubleshoot multiple complex biologics oriented BDS manufacturing processes, simultaneously.
- Assist in the design, preparation, execution and review of the process validation and required BLA filing requirements.
- Assures that patients continue to receive high quality biologics / monoclonal antibody derived products approved and commercialized by the Company. 40%
- Monitors, trends and analyzes key process, critical process manufacturing data and An uninterrupted supply chain requires that the manufacturing product quality attribute data from commercial manufacturing batches to identify, recommend and implement strategic opportunities to improve process robustness and assure uninterrupted supply of high quality product to patients. Participates in the review of process characterization and PPQ approaches to facilitate licensure and may provide support during regulatory inspections. Process is robust and in control at all time. This activity provides signals of potential trends / shifts in performance which can be addressed in a proactive vs reactive manner. 20%
- Works closely and in collaboration with MDC/PST/Exton teams on any BDS related new product initiatives, upstream related investigations during the PPQ stage and/or clinical trial manufacturing campaigns. Provides a coordinated, bounded, sound technical assessment in the evaluation, resolution and close out of deviations / investigations 15%
- Works closely and in collaboration with MDC/PST/Exton teams during BDS technology transfer initiatives, late stage clinical trial manufacturing and PV activities conducted in-house or at CMOs.
- Provides flexibility and opportunity to rapidly adjust to changes in market demands and/or changes in the supply chain network. 15%
- Leads EDCS BDS technology transfer initiatives, process improvement projects, risk assessments and comparability assessments between the Company and CMO after commercialization.
- Leads, coordinates and directs cross-functional, cross-departmental, cross-company biologics related process investigation / deviation teams to a rapid and successful identification of root cause and close out of any CAPA after commercialization (post licensure commitments). Establishes, maintains and facilitates collaboration with other biologics
- Networking within the biologics network and externally is essential manufacturing subject matter experts within the Company (OBL, MDC/ PST/Exton, EDCS Bio DCU) as well as across the pharmaceutical industry and strategic to our being innovative, informed on advances in relevant technology and aware of industry trends. 10% Establishes and maintains open communication and collaboration with other key EDCS stakeholders (e.g. Product Champion, Planning, Quality, Regulatory)
- Strategic assurance of an un-interrupted supply of product to patients.
- The complexity of the BDS manufacturing process and therefore the potential impacts on product quality attributes is greater for biologics than for traditional small molecule production. The candidate must have the training, skills and experience in medium to large scale upstream antibody/protein production and harvesting operations, working cell bank management and other technical functions commensurate with the job description.
- CMO management requires a unique skill set when compared to management of internal resources. The ideal candidate would have technical abilities that are well above average in order to solve problems with confusing or limited data, as well as to influence and convince CMOs to implement technical strategies proposed by the Company. Must be able to rapidly see the big picture and assess the impact of data and/or decisions across the board.
- Must have strong communication skills and be able to work with diverse teams in stressful environments where resources and time may be limited to operate in a clear, decisive manner and reach independent, sound solutions during normal and time-critical situations.
- Advanced degree in biology, biochemistry, chemical engineering or a related field (preferred). BS degree with a minimum of 10+ years hands-on biologics manufacturing experience
- Experience working in a contract manufacturing organization or prior experience managing contract manufacturing (good interpersonal communication skills are a must
- Familiarity with authoring and review of CTD sections specific to process development, process validation, analytical, manufacturing and facilities. Knowledge and experience with biologics manufacturing operations (e.g. cell culture, fermentation, primary recovery, protein purification)
- Familiarity with risk-assessment tools, knowledge of scale-down models, validation requirements for biological processes, analytical methods and facilities.
- Strong verbal, presentation and technical writing skills. Ability to communicate in Japanese (is a plus)
- Must be self-directed, goal-oriented, quality conscious and team focused. Strong project management skills
Please submit your resume for consideration. Once submitted, feel free to contact Sanka at 646-856-8903 for additional information.
Approx. Duration: Perm
About Hired By Matrix
Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.
Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
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*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.
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