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Associate Director, Injectables Drug Product Development

New Haven, CT 06510

Posted: 12/13/2022 Employment Type: Direct Hire/Perm Job Category: Scientific Job Number: 523588 Is job remote?: No Country: United States

Job Description

This is what you will do:

The candidate will lead and/or direct the process development, characterization, technology transfer, manufacturing support, and validation of liquid and/or lyophilized injectable drug products (DP) spanning synthetic, peptide, nucleic acid and protein modalities in vials as well as pre?lled syringes and cartridges. The candidate will be responsible for the development of a variety of drug product manufacturing unit operations including, but not limited to, freeze/thaw, mixing, sterile filtration, vials/syringes/cartridge filling, stoppering/sealing, visual inspection, transportation. Hands on experience with biotherapeutics drug product development, including a detailed understanding of the manufacturing unit operations is required.

The position will report to the Senior Director of Drug Product Process Development and Technology Transfer and contribute to optimizing the DP development and technology transfer methodology, manufacturing support role, as well as the forecast and management of resource (e.g., FTEs, materials, costs, etc.). The candidate will also lead elements of manufacturing support including but not limited to weekly support meetings, and as necessary in person on-site manufacturing support.  Manufacturing support activities includes but not limited to sending/receiving site process gap analysis, process FMEAs, change control, deviations, CAPAs, master batch record review, at-scale/full scale process development studies as well as developing relevant control strategies. Experience utilizing electronic Quality system such as Trackwise is a desirable.

The position will be a senior member of the Injectable Drug Product Development team and must collaborate and network with other departments within Product Development and Clinical Supplies (PDCS) as well as with Global Operations, Quality and Regulatory organizations. The ideal candidate will lead elements of the design and implementation of phase appropriate process development and technology transfer technical approaches that are aligned with regulatory expectations.

You will be responsible for:
  • Leading drug product development teams (DPTs) and/or supervises leaders of DPTs consisting of multiple cross functional stakeholders, as well as understand the cross functional implication of project activities and decisions.
  • Driving creation of scientific/technical project proposals based on corporate or project objectives as well as lead critical development programs as needed.
  • Leading and/or supervising the design and execution of process development studies for drug candidates, as well as supports technology transfer activities to internal manufacturing and contract manufacturing sites
  • Understanding "big picture" for projects and tasks involved and prioritize work of self and others accordingly.  Prioritizing multiple assigned tasks and projects and leads project teams consisting of one or more junior team members. The ability to work independently as well as part of the team is essential.
  • Performing and/or supervising in depth data analysis, authoring of reports and/or relevant sections of regulatory filings for drug product candidates
  • Being current with literature regarding drug product manufacturing processes, equipment, and single use systems as well as global regulatory expectations
  • Leading the development of project presentations to PDCS Senior Management.  Communicates effectively with peers and actively participates in department and team meetings including assuming ownership and delivering on action items.

You will need to have:
  • PhD in Chemistry, Biochemistry, Biophysics, Pharmaceutical Sciences, Bio/Chemical Engineering, or relevant field with 8+ years, a MS with 17+ years or BS with 18+ years of relevant experience. Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred.
  • At least 3-4+ years of experience in managing scientists or engineers with to enable drug product process development and manufacturing support for early as well as late-stage programs through licensure. Experience in biotherapeutics development as well as understanding of the biotechnology products life cycle
  • Scientific and practical knowledge of protein biochemistry, protein formulation/stability, biotherapeutic analytical methods, as well as biotherapeutic drug product process development is essential.
  • Hands-on experience with defining DP processes, scale up, transferring information between development and manufacturing sites, document preparation, as well as knowledgeable in cGMP and Quality expectations.
  • Excellent interpersonal skills are required, including the ability to communicate effectively from associate scientists to the senior management level.
  • The duties of this role may include elements of a lab-based role where employees must be able, with or without an accommodation: lift/carry 15/30 pounds unassisted/assisted; with biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging
  • The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
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