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Manager - Upstream Process Development

  • Job type: Permanent
  • Location: New York
  • Salary: Negotiable
  • Job reference: 299551/002_1559757783
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 05/06/2019

Upstream Process Development - Leadership Role

Publicly traded biopharmaceutical company with a healthy pipeline of cutting edge oncology treatments for unmet medical need is seeking a Manager/Associate Director of Upstream Process Development and Production. We are looking for a hands on, high energy, technical expert who wants to be part of a team delivering exciting new products to the market. This position reports to the Head of Process Development and Manufacturing.

Responsibilities:

The successful candidate will be responsible for upstream process development and production of monoclonal antibodies, through collaboratively working with multiple CMOs on various development and technology projects, providing both technical oversight and strategic guidance in a fast-paced environment. S/he will play a key role in implementing and aggressively driving plans for CMC activities related to the company's products in development. The individual should have experience in development and optimization of biologics manufacturing processes, risk assessment, process characterization, process validation, BLA-enabling supporting studies, clinical and commercial manufacturing. The position liaises with other operational disciplines and external partners to effectively conduct technology transfer and manage outsourced development, manufacturing and related activities. Deep technical expertise and hands-on experience in upstream process development and cGMP manufacturing of monoclonal antibodies is required.

Duties & Responsibilities:

  • Candidate will be responsible for upstream process development, scale-up, production and tech transfer of processes within or between CMOs.
  • Ensures all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO.
  • Develops highly productive upstream processes in a timely manner for novel antibody therapeutics.
  • Designs robust and scalable upstream processes using scientific and engineering principles, considers configurations of various bioreactor and process formats.
  • Improves workflow efficiency and overall process yield in conjunction with cell line development, downstream process development, and analytical & formulations development teams.
  • Prepares CMC portions of regulatory submissions and updates (IND, BLA, etc.)
  • Designs, manages and supports process characterization studies and develops control strategies for process validation.
  • Conducts process investigations and helps determine root cause of excursions in clinical manufacturing.
  • Works effectively with team members and contractors both in-person and remotely. Provides direction, support, and corrective action as needed.
  • Ensures that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
  • Serves as SME in the upstream process (such as handling large sets of data including statistical analysis using specific software, familiarity with certain approaches such as QbD and Control Strategy Development or detailed knowledge or multivariate analysis and DoE approaches).

Requirements:

  • BS/MS/PhD in chemical/biochemical engineering, cellular biology, biochemistry or a related discipline. Bachelor's degree with minimum of 12 years, MS with minimum of 8 years and PhD with minimum of 4 years of directly related experience in a relevant scientific discipline is required
  • Experience with various mammalian cell lines including NS0, SP2/0 and CHO cell lines is required
  • Demonstrated deep knowledge and understanding of cGMP compliance requirements
  • Current knowledge of relevant regulatory requirements related to biologic manufacturing and analytical methods to ensure compliance in all activities
  • Experience with data tracking and trending, principal component analysis, or DOE a plus (statistical software experience preferred).
  • Dynamic individual with excellent, clear written and verbal communication skills including technical/business writing. Demonstrated self awareness, keen interpersonal skills and team work at all levels.
  • Ability to set priorities, work independently and deliver results in a timely manner, displaying laser focus and a sense of urgency.
  • Strong planning, organizational and leadership skills.
  • Experience in radiopharmaceutical manufacturing process is a plus.
  • Outstanding technical writing skills.

To apply: Please include a detailed resume in MS Word format and preferred method of contact.

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