Supervisor, Commercial Manufacturing, 2nd Shift jobs in United States
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Orca Bio · 1 month ago

Supervisor, Commercial Manufacturing, 2nd Shift

Orca Bio is a late-stage biotechnology company focused on redefining the transplant process through next-generation cell therapies. The Supervisor, Commercial Manufacturing plays a critical role in overseeing the production of cell therapy products, ensuring adherence to quality standards and regulatory requirements while supervising a team of associates during the 2nd shift operations.

Health CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Supervise and lead a team of associates, cell therapy production, oncology during assigned shift operations
Coordinate daily manufacturing activities to meet schedule, and quality and compliance goals
Execute and enforce cGMP-compliant SOPs, batch records, and safety procedures
Provide on-the-floor training, mentorship, and performance feedback to production staff
Monitor and troubleshoot production activities and equipment, escalating as needed
Partner with QA and QC to support in-process checks, deviation investigations, and batch record reviews
Maintain real-time, accurate documentation of manufacturing processes and equipment use
Support continuous improvement initiatives to increase reliability and efficiency
Participate in CAPA and deviation investigations related to manufacturing activities

Qualification

Aseptic manufacturing practicesClean room operationsSupervisory experienceCell therapy experienceDeviation investigationsWork ethicInterpersonal skillsProblem-solving skillsAttention to detailTeam collaboration

Required

B.S. degree required in biology or related field
2+ years of supervisory or team experience is required
Strong understanding of aseptic manufacturing practices and clean room operations
Ability to gown and work in clean rooms and Biosafety safety cabinets
Highly detail oriented with special attention to quality
Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Strong interpersonal skills and ability to communicate effectively
Ability to work in a collaborative manner
Ability to work independently and as part of a team
Highly tolerant and respectful of all team members
A sense of humor is always appreciated
Strong problem-solving skills
Must be able to remain in a stationary position 50% of the time while in a biosafety cabinet/cleanroom environment which includes wearing a PPE gown
Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
Occasional need to ascend/descend stairs within workspace; job requires standing/walking

Preferred

M.S. degree in biology or related field
Prior experience in cell therapy or other advanced biologics
Familiarity with deviation investigations, CAPAs and change control processes

Benefits

Competitive medical, dental, and vision benefits
Flexible PTO
401(k) plan
Life and accidental death and disability coverage
Parental leave benefits
Free daily lunches and snacks at our on-site locations

Company

Orca Bio

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Orca Bio is a clinical-stage cell therapy company dedicated to delivering curative medicine to patients.

H1B Sponsorship

Orca Bio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2021 (1)
2020 (1)

Funding

Current Stage
Late Stage
Total Funding
$542M
Key Investors
Lightspeed Venture PartnersSilicon Valley Bank
2026-01-09Series F· $250M
2026-01-09Debt Financing· $100M
2020-06-17Series D· $192M

Leadership Team

J
Jeroen Bekaert
Co-Founder and Chief Operating Officer
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Company data provided by crunchbase