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Direct Hire - Senior Manager, DI+Biologics
Ref No.: 18-11580
Location: Exton, Pennsylvania
Start Date / End Date: 09/24/2018 to 12/23/2018
Job Summary
The person in this position will assure that commercial bulk drug substance (BDS) manufacturing processes in Client’s supply chain (internal or external) for production of biologics (monoclonal antibodies and proteins) and any antibody drug conjugate (Client) based products are robust, scalable, well controlled and capable of providing the highest quality product to patients. 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 Client’s success in commercializing BDS manufacturing for Client’s current late stage development pipeline (KANAb-001, MORAb-003) and future biologics Client 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.

Essential Functions / Responsibilities
Major Activities
(What the job does)
End Result
(Why it is done)
% Time
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 Client.
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 CMO’s.
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 Client 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 Client biologics network and externally is essential manufacturing subject matter experts within Client (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.

Scope Measures
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 Client. 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.

Knowledge/Skills/Abilities Required
(A) Minimum
(B) Desirable But Not Essential
Advanced degree in biology, biochemistry, chemical engineering or a related field (preferred)
Experience working in a contract manufacturing organization or prior experience managing contract manufacturing (good interpersonal communication skills are a must)
BS degree with a minimum of 10+ years hands-on biologics manufacturing experience
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
The statements