Downstream Manufacturing Manager/Sr. Supervisor

3 months ago

San Pablo, United States 153136 JOINN Biologics Full time
Job DescriptionJob DescriptionDescription:

About JOINN Bio

JOINN Biologics (JOINN Bio) is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We will work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry


Downstream Manufacturing Manager/Senior Supervisor

This position will oversee all aspects of JOINN’s day to day operations related to downstream manufacturing processes while ensuring delivery of customer commitments. The Downstream Manufacturing Manager/Sr. Supervisor is responsible for the supervision of Downstream manufacturing staff and operations as well as direct execution of operational activities.


Job Responsibilities

  • Management and execution of downstream operations including but not limited to:
  • Solution preparation, purification (Column and Membrane), Viral Inactivation, Filtration operations, Formulation and Filling operations.
  • Training of the downstream team in downstream operations.
  • Planning and coordination of daily, weekly and monthly downstream execution activities.
  • Ensure batch records, standard operating procedures (SOPs) and Current Good Manufacturing Practice (cGMP) regulations are rigorously followed to ensure manufacturing operations are safe and compliant.
  • Active troubleshooting and assessment of current process efficiencies to minimize various risks and promote continuous improvement.
  • Planning of raw material /consumables for production campaigns.
  • Reporting and documentation of non-conformities and participation in investigations and creation and implementation of corrective/preventive actions in specific areas of operation.
  • Creation, Revision and/or Review of documents including but not limited to:
  • Standard Operating Procedures (SOPs)
  • Downstream Process Descriptions (DSPRD)
  • Bill of materials (BOM)
  • Batch Manufacturing Records (BPRs)
  • Downstream Production Reports (DPR)
  • Change Controls (DCRs and CCRs)
  • Management of equipment operational status which includes but is not limited to:
  • Ensuring maintenance of operations equipment in coordination with Facilities Department and equipment vendors.
  • Process equipment commissioning & qualification support.
  • Method and Recipe creation and review for operating equipment (especially AKTA Systems).
  • Management of the downstream operators and technical staff including but not limited to:
  • Lead department operational huddles as needed
  • Mentor junior staff on downstream technical operations, right-the-first-time principles, cGMP compliance, Safety in the workplace, process efficiency, task management and communication.
  • Encouraging and motivating direct reports and assessing performance
  • Possess the knowledge and exposure to Environment, Health, Safety, and Sustainability (EHSS) practices and follow and promote Environment, Health, Safety, and Sustainability (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
  • Ability to work effectively in a cross-functional, team-based environment in close collaboration Process Development (PD), Facilities (FAC and SUP) and Quality departments (QA and QC).
  • Act at a delegate for supervisor during cross functional team meetings as needed.
  • Able to work off shift hours and weekend as needed to complete campaigns.
Requirements:
  • Minimum of 5 years of experience in downstream process manufacturing with 2 years of supervisory experience.
  • Expertise in downstream unit operations.
  • Strong hands-on experience with Chromatography and filtration systems.
  • Exposure to handling of recombinant proteins and biotheraputics projects in cGMP area.
  • Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects.
  • Strong technical writing skills
  • Proven problem-solving skills and quick decision-making abilities
  • Exceptional communication skills
  • Experience with support of Equipment Qualification and commissioning aspects.

JOINN Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status

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