Downstream Manufacturing Operations Manager

3 weeks ago

Richmond, California, United States Joinn Biologics Full time
About JOINN Bio

JOINN Biologics is a Bay Area, California-based company dedicated to advancing biopharmaceutics through premier contract development and manufacturing services for biologics and advanced therapies.

We strive to provide a comprehensive range of services from early custom development to clinical manufacturing for our global clients.

We work closely with our partners and clients to accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry.

Downstream Manufacturing Manager/Senior Supervisor

This position oversees 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 supervising Downstream manufacturing staff and operations as well as direct execution of operational activities.

Key Responsibilities
  • Management and execution of downstream operations, including solution preparation, purification, 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.
  • Ensuring 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 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, including ensuring maintenance of operations equipment in coordination with Facilities Department and equipment vendors, process equipment commissioning & qualification support, and method and recipe creation and review for operating equipment.
  • Management of the downstream operators and technical staff, including leading department operational huddles as needed, mentoring 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.
  • Possessing knowledge and exposure to Environment, Health, Safety, and Sustainability (EHSS) practices and following and promoting 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 with Process Development (PD), Facilities (FAC and SUP), and Quality departments (QA and QC).
  • Acting as a delegate for supervisor during cross-functional team meetings as needed.
  • Able to work off-shift hours and weekends 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 biotherapeutics 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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