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Biologics - Upstream/Production Manufacturing Manager

Abzena San Diego, CA
  • Posted: over a month ago
  • Full-Time
  • Benefits: Vision, Medical, Life Insurance, 401k, Dental

Current Responsibilities:

  • Leads, mentors, and trains all manufacturing employees in execution of production activities, serves as a role model and provides career development and direction.
  • Responsible for specific product-related operations in cell culture/fermentation. Functions as a Subject Matter Expert for manufacturing.
  • Responsible for specifically assigned projects, to include monitoring project timelines, ordering supplies, and communication of project status to Scientific/Manufacturing senior management.
  • Responsible for all activities involving aseptic technique and maintains production equipment with single-use materials as it relates to cell culture (Stir-Tank bioreactors, Wave bioreactors, incubators, shakers, and cell separation equipment).
  • Provides detailed observations, analyzes data, and interprets results. Communicates these results to others.
  • Initiates deviations, assesses product quality impact, and proposes and executes Corrective and Preventative Actions (CAPA).
  • Reviews and approves SOPs, master batch records, and other cGMP documentation Prepares technical reports, summaries, protocols, batch records and quantitative analyses as needed.
  • Change owner for implementation or revision of equipment, documentation, and material specifications.
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Supports multiple projects simultaneously.
  • Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
  • Develops effective working relationships with both internal and external partners.
  • Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
  • Assists coordinating with downstream operations.
  • Provide input and feedback on performance of production associates and lab technicians.
  • Performs other related duties as required.

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena policies and procedures.
  • Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of Abzena business.
  • Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena strategic goals.
  • May cross-train on various tasks including Downstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.
  • Travels as needed to attend professional conferences, train on new technologies, and execute process transfer in support of clients.
  • May cross-train on various tasks including Downstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.

Qualifications/Skills Required:

  • BA/BS or MA/MS degree that included laboratory work in biology, microbiology, chemical engineering or related field.
  • Minimum five (5) years of experience with MA/MS or minimum eight (8) years with BA/BS as an Upstream/Production Associate, or equivalent, in a GMP environment. Supervisory role experience a must.
  • Knowledge of mammalian cell culture for production of biopharmaceuticals.
  • Skill with aseptic technique, bioreactor operation and single-use technologies following SOPs, batch records and working within a cGMP regulated environment.
  • Demonstrated ability to observe technical issues and directs troubleshooting of process and equipment problems.
  • Ability to organize workload, oversee workload of direct reports, and relevant resource requirements.
  • Skill in leadership duties, to include time management and planning.
  • Ability to successfully perform multiple tasks, when required.
  • Ability to safely operate production equipment in accordance with established practices.

Abzena

Why Work Here?

If you are looking for a dynamic environment where you can grow and excel your career, then Abzena is the place for you!

About Abzena Abzena is a life sciences group with its headquarters in the UK and two sites in the US. Abzena offers a range of complementary services and technologies for the selection, development and manufacture of biopharmaceuticals, products based on antibodies or other proteins. Working with companies and academic groups all over the world, including most of the top 20 biopharmaceutical companies, Abzena supports the development and manufacture of better treatments for patients. Eleven antibodies which have been created using Abzena's technologies (ABZENA inside products) are currently being progressed through clinical development by our licensees. More information on our ABZENA inside products is available here. Abzena was created through the incorporation of Antitope, PacificGMP, PolyTherics, The Chemistry Research Solution (TCRS) and Warwick Effect Polymers, all of which now trade as Abzena.

Address

8810 Rehco Road San Diego, CA 92121
San Diego, CA
USA

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