Position Summary

OPM Biosciences is establishing a new GMP-aligned manufacturing facility in the U.S. We are seeking a Manufacturing / Media Production Manager to build and lead cell culture media manufacturing operations from the ground up.

This role is responsible for GMP-compliant manufacturing execution, process setup, and scale-up of cell culture media production, ensuring robust, reproducible, and high-quality output.

Key Responsibilities

• Lead GMP manufacturing operations for cell culture media, including mixing, formulation, sterile filtration, and dispensing

• Develop and execute SOPs, batch manufacturing records (BMRs), and GMP production workflows

• Support technology transfer from R&D to manufacturing and scale-up activities

• Ensure compliance with GMP requirements, batch documentation standards, and data integrity principles (ALCOA+)

• Manage deviations, CAPA, and change control processes in collaboration with QA/QC

• Oversee production equipment operation, qualification, and maintenance support

• Build, train, and develop the production team while driving operational excellence initiatives

Qualifications

• Bachelor’s or Master’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field

• 5–10+ years of experience in GMP manufacturing, biopharmaceutical production, or cell culture media manufacturing

• Hands-on experience in aseptic processing, sterile filtration, or media formulation at production scale

• Strong knowledge of GMP systems, batch documentation, and regulatory expectations (FDA/EMA preferred)

• Proven experience in deviation investigation and CAPA execution

Preferred Experience

• Experience in greenfield GMP facility startup or major facility expansion

• Background in cell culture media, upstream bioprocessing, or biopharma raw material manufacturing

• Familiarity with single-use technologies and closed-system processing

• Experience in cross-functional tech transfer (R&D → Manufacturing → QA)

• Lean / Six Sigma certification is a plus

• Working Conditions / Physical Requirements

  • Ability to stand, walk, and move materials throughout warehouse and laboratory support areas on a daily basis

  • Ability to occasionally lift up to 35 lbs

  • Ability to support early or late manufacturing schedules when required

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable law.

Note

This job description is intended to describe the general scope of the role. Responsibilities may evolve as the Pleasanton site ramps and organizational needs change.

Pleasanton, CA 
Full-time | On-site, 9 AM - 5 PM

We’re seeking a self-starter, motivated, and passionate Inside Sales & Customer Operations Specialist to join our expanding U.S. commercial team in Pleasanton, CA. This role requires a curious, hunter-minded individual who thrives on discovering new opportunities, engaging with customers, and helping them find the best solutions for their bioprocess needs. You’ll play a key role in driving lead generation, nurturing relationships, and supporting post-sales operations as part of OPM’s mission to accelerate the growth of our U.S. cell-culture business.

This position will support customer engagement and account development activities across the entire United States, collaborating closely with regional account executives and business development leaders.

Key Responsibilities

• Drive lead generation through CRM and sales-enablement tools (LinkedIn Sales Navigator, HubSpot, Salesforce).
• Qualify and nurture leads, conduct outbound calls, follow-ups, and customer outreach.
• Proactively hunt for new business opportunities and identify emerging customer needs within target accounts.
• Collaborate with Sr. BD Manager and marketing team to execute targeted campaigns and events.
• Support post-sales activities including PO processing, order tracking, and customer onboarding.
• Maintain accurate CRM data, update opportunities, and support pipeline forecasting.
• Partner with technical sales specialists to align on project needs and account strategy.
• Participate in cross-functional initiatives—marketing, operations, and logistics—to ensure a seamless customer experience.
• Identify and develop opportunities for upselling or transitioning into field sales roles as the business scales.
  
  

Qualifications

• B.S. in Biology, Biochemistry, Biotechnology, or related field (M.S. a plus).
• 2-4 years of experience in inside sales, customer success, or post-sales support within life sciences or similar technical environments.
• Familiarity with bioprocessing, cell-culture media, or lab consumables preferred.
• Experience using CRM and sales-enablement tools (HubSpot, Salesforce, LinkedIn Sales Navigator, etc.).
• Strong hunter mentality, driven to pursue new leads and exceed targets.
• Excellent written and verbal communication with a curious, adaptable, and collaborative mindset.
• Strong organizational skills and attention to detail in documentation and follow-through.

OPM BIOSCIENCES INC is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We evaluate applicants based on their qualifications and merit, and our hiring decisions are made to support diversity and inclusion in the workplace.

Pleasanton, CA 
Full-time | On-site

As the QA Manager, you’ll build and run the Quality System for our U.S. R&D and pilot operations—covering cell line development (CLD), cell culture process development, and small-scale powder/liquid media production. You’ll own document control, deviations/CAPA, batch record review, supplier quality, and lot release, while getting the site “GMP-ready” as we scale.

Key Responsibilities

Quality Management System (QMS)

• Stand up and maintain a phase-appropriate QMS (SOPs, forms, records) aligned with cGMP principles, ISO 9001/13485 good practices, and ICH Q9 risk management.
• Own document control, training, change control, deviations/investigations, CAPA, and management review.
• Implement data-integrity by design (ALCOA+), including audit trails and controlled lab notebooks/eQMS.

CLD & Cell Culture Development QA Oversight

• QA oversight of cell banking (RCB/WCB): qualification, traceability, storage, chain-of-custody.
• Ensure biosafety & compliance for BSL-2 labs; oversee mycoplasma/sterility policies & materials control.
• Review study plans, protocols/reports (DoE, comparability), and ensure reference standards control.
• Approve deviations, investigations, and corrective actions tied to development studies.

Small-Scale Media Production QA Oversight

• Establish batch record issuance, review, and lot release (spec, COA, label control).
• Define in-process/finished product specs (appearance, pH, osmolality, bioburden/endotoxin, clarity, assay).
• Oversee equipment qualification (IQ/OQ/PQ), calibration, maintenance logs, and cleaning validation.
• Set up environmental monitoring (ISO-classified rooms as applicable) and gowning/behavioral controls.
• QA support for sterile filtration (filter integrity), powder blending, mixing, packaging, and labeling.

Supplier & Materials Quality

• Qualify raw-material suppliers (audits/questionnaires), set incoming inspection plans, manage SCARs.
• Define material specifications and change-notification requirements; maintain approved supplier list (ASL).

Audits, Compliance & Readiness

• Lead internal audits; host client audits; coordinate responses/closure.
• Build phase-appropriate validation/qualification and change-management strategies for GMP readiness.
• Partner with EHS on biosafety/chemical compliance and waste management.

People, Training & Culture

• Build a small but high-performing QA team; coach R&D/Operations on quality best practices.
• Own quality training curricula and effectiveness checks across functions.
• Champion continuous improvement (Lean/6σ mindset) and right-first-time execution.

Qualifications

• 6+ years in Quality within biologics, cell culture, media, CDMO, or adjacent life-sciences manufacturing; 2+ years in a QA lead/manager role.
• Hands-on experience with CLD/cell culture workflows and pilot-scale media production (powder and/or liquid).
• Strong command of cGMP principles, ISO 9001/13485, ICH Q7/Q9, data integrity (ALCOA+), and phase-appropriate compliance for R&D → clinical scale-up.
• Proven track record standing up QMS elements (deviations/CAPA, change control, doc control, batch review, training).
• Exposure to equipment/utilities qualification (e.g., cleanrooms, HVAC, PW/DI water, cold rooms), EM programs, and quality risk management.
• Excellent cross-functional communication; comfortable working with both scientists and operators.
• Bachelor’s in life sciences or engineering required; advanced degree a plus.

Nice to have

• Start-up/CDMO experience; client-audit hosting.
• eQMS/LIMS experience; statistics for trending (e.g., control charts, process capability).
• Familiarity with sterile filtration, endotoxin control, and cleaning validation for media operations.

OPM BIOSCIENCES INC is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We evaluate applicants based on their qualifications and merit, and our hiring decisions are made to support diversity and inclusion in the workplace.

Position Summary

The QC Manager will lead quality control for the Pleasanton site, with responsibility for analytical, microbiology, environmental / support testing, and release readiness for cell culture media production. This role will establish fit-for-purpose QC systems, build the team, and ensure the site can support startup, routine operations, investigations, and continuous improvement.

Key Responsibilities

• Lead QC strategy and day-to-day execution across analytical, microbiology, assay, and environmental-support activities for media production.
• Build and manage QC workflows for raw material testing coordination, in-process support, finished goods release testing, stability support, and special studies as needed.
• Own QC laboratory readiness, including equipment, methods, scheduling, sample flow, reagents, reference materials, and documentation.
• Partner with QA, Production, Warehouse, and Technical teams on specifications, investigations, deviations, CAPAs, change controls, and lot disposition support.
• Establish a practical and scalable QC organization covering analytical and microbiology functions for startup and early operations.
• Ensure data integrity, good documentation practices, logbook control, and inspection readiness across the QC function.
• Support transfer, qualification, verification, and lifecycle management of QC methods relevant to media production and performance testing.
• Own QC SOPs, test forms, training plans, analyst qualification, and lab performance metrics.
• Manage contract labs and external testing partners where internal capability is not yet built out.
• Drive issue resolution with urgency while maintaining scientific soundness and quality expectations.
• Serve as a strong cross-functional leader who can help shape a pragmatic startup quality culture.

Qualifications

• Bachelor’s, Master’s, or PhD in chemistry, biochemistry, biology, microbiology, or a related scientific discipline.
• 8+ years of QC experience in biotech, media, or another regulated life sciences environment, with prior leadership experience.
• Strong understanding of analytical and microbiology lab operations, investigations, documentation, and quality systems.
• Experience supporting startup, scale-up, or new-site QC readiness is highly preferred.
• Able to build practical systems quickly without losing control of quality fundamentals.

Preferred Experience

• Experience with cell culture media, raw material variability, performance assays, and micro / sterility-related workflows.
• Hands-on familiarity with instruments such as HPLC/UPLC, Maurice or similar protein analysis tools, osmometer, and standard QC lab equipment.
• Experience managing both internal testing and external / contract testing strategies.

Working Conditions / Physical Requirements

• Able to work on-site in laboratory and controlled environments daily.
• Able to support occasional off-hours or weekend work tied to investigations, critical testing, or startup milestones.

Note

This job description is intended to describe the general scope of the role. Responsibilities may evolve as the Pleasanton site ramps and organizational needs change.

OPM BIOSCIENCES INC is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We evaluate applicants based on their qualifications and merit, and our hiring decisions are made to support diversity and inclusion in the workplace.

Position Summary

The Warehouse / Logistics Manager will build and run an organized, compliant, and highly reliable materials operation for the Pleasanton site. This role will own receiving, storage, inventory control, internal material movement, and outbound logistics for raw materials, consumables, intermediates, and finished media while supporting startup ramp and routine operations.

Key Responsibilities

• Own warehouse and logistics operations, including receiving, quarantine, release staging, storage, picking, shipping, and cycle counting.
• Set up practical warehouse zoning for raw materials, released goods, non-conforming material, cold storage, hazardous materials, and outbound staging.
• Implement and maintain accurate inventory control, lot traceability, FEFO/FIFO rules, and reconciliation practices.
• Partner closely with QA, Production, QC, Procurement, and Finance on material status, usage, and transaction accuracy.
• Coordinate inbound and outbound shipments, including domestic freight, cold-chain shipments, documentation, and carrier management.
• Manage warehouse layout, racking, labeling, material flow, and visual controls to support safe and efficient startup operations.
• Ensure compliant storage and handling of chemicals, gases, temperature-sensitive materials, and waste-related staging where applicable.
• Develop warehouse SOPs, forms, training records, and KPI reporting for inventory accuracy, on-time shipment, and dock-to-stock performance.
• Support ERP / inventory system setup, transaction discipline, barcode / label workflows, and physical count processes.
• Lead root cause investigations and corrective actions for shipping errors, inventory discrepancies, damaged goods, and material excursions.
• Build and manage relationships with freight forwarders, local carriers, and key suppliers to improve service and cost.

Qualifications

• Bachelor’s degree or equivalent experience in supply chain, operations, logistics, business, or a related field.
• 5+ years of warehouse / logistics experience in biotech, pharma, life sciences, or another regulated industry.
• Strong understanding of inventory control, warehouse flow, lot traceability, and quality status segregation.
• Experience with ERP or inventory systems and strong transaction discipline.
• Comfortable working hands-on in a startup environment while also setting processes, metrics, and controls.

Preferred Experience

• Experience with raw material handling for media, biologics, chemicals, or lab supplies.
• Familiarity with hazardous materials storage, cold-chain logistics, and regulated shipping documentation.
• Forklift / pallet handling experience and practical knowledge of warehouse rack planning preferred.

Working Conditions / Physical Requirements

• Able to stand, walk, and move materials through warehouse and lab support areas daily.
• Able to lift up to 35 lbs occasionally.
• Able to support periodic early / late shipment windows when needed.

Note

This job description is intended to describe the general scope of the role. Responsibilities may evolve as the Pleasanton site ramps and organizational needs change.

 
To apply, email your resume to opmus_hr@opmbiosciences.com.

OPM BIOSCIENCES INC is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We evaluate applicants based on their qualifications and merit, and our hiring decisions are made to support diversity and inclusion in the workplace.