Manufacturing Lead/Manager

Location
92121, San Diego
Posted
Jun 20, 2018
Required Education
Bachelors Degree
Position Type
Full time

Responsibilities:

  • Assumes lead role in various biological research projects.
  • Specific product-related operations in cell culture/fermentation. Functions as a Subject Matter Expert for manufacturing.
  • Leads and mentors upstream staff, serves as a role model and provides career development and direction.
  • Operates and maintains production equipment as it relates to cell culture – fermentation.
  • Proposes, plans, organizes and executes manufacturing in production-scale protein manufacturing.
  • Performs a variety of complex tasks independently and in accordance with current GMPs.
  • Maintains records to comply with regulatory requirements and conducts in-process testing.
  • 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.
  • Change owner for implementation or revision of equipment, documentation, and material specifications.
  • Prepares technical reports, summaries, protocols, batch records and quantitative analyses.
  • 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.
  • Provides training to new personnel in a specific technical process.
  • Provides feedback to Senior Management.
  • Operates to the highest ethical and moral standards.
  • Complies with the client’s policies and procedures.
  • Adheres to quality standards set by regulations and the client’s policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of the client’s business.
  • Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting the client’s 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.

 

Requirements:

  • BS degree in an applicable scientific field with minimum 8 years of experience in a cGMP manufacturing/laboratory environment, with 2 of those being in a supervisory role. Or MS with at least 5 years industrial experience in process development and cGMP manufacturing.
  • Knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest.
  • Skill with manufacturing of products following SOPs, batch records and working within a cGMP regulated environment.
  • Ability to observe technical issues and directs troubleshooting of process and equipment problems.
  • Ability to independently operate complex systems and equipment and optimizes their use in manufacturing in accordance with defined goals.
  • Knowledge of specific product-related operations in cell culture/fermentation.
  • Skill leading Upstream Department in execution of production and process development related activities.
  • Ability to ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
  • Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions.