Oligo Manufacturing Lead - Swing shift
About The Position
The Oligo Manufacturing Lead works directly with the departmental Supervisor and Manager to ensure that GMP Manufacturing Lab functions comply with company procedures and external regulatory requirements. The role performs and supports GMP oligonucleotide manufacturing, operates instruments in the immediate work area, and helps the group meet performance objectives through tracking, reporting, and timely completion of product and process quality activities. The lead also supports training and adherence to SOPs, provides technical guidance to team members, assists with manufacturing procedures and documentation, and initiates and executes quality system records. The role is based on-site in Petaluma, California, and is associated with the swing shift. The schedule depends on the Production Lab and shift; overtime may be required as workload demands and with manager pre-approval. No travel is required. Safe handling of hazardous chemicals and adherence to PPE requirements are part of the work.
Requirements
- Bachelor’s degree in a related field, or at least 2 years of equivalent industry experience and training and/or demonstrated ability to meet GMP Technician requirements.
- Ability to add, subtract, multiply, and divide units of measure using whole numbers, common fractions, and decimals.
- Microsoft Office, Outlook, Word, Excel, and web browser skills.
- Ability to work independently and as part of a team.
- Professional presence and strong attention to detail.
- Technical proficiency to execute documented procedures effectively.
- Ability to multitask in a fast-paced environment and use a methodical approach to tasks.
- Strong communication and problem-solving abilities.
- Ability to safely use hazardous chemicals and follow PPE requirements.
Nice To Haves
- Experience or knowledge of instrumentation such as HPLC, MS, Purifiers, Spectramax, SpeedVacs, Liquid Handlers, TFF, and pipettes.
- Knowledge of Unicorn and Empower software.
Responsibilities
- Perform or support departmental GMP oligonucleotide manufacturing functions according to established procedures.
- Operate and manufacture product using all instruments in the immediate work area.
- Make decisions guided by policies and procedures that affect the group’s ability to meet performance objectives.
- Use tracking and reporting systems to drive performance and ensure timely completion of product and process quality work.
- Identify equipment or related documentation issues and take appropriate corrective action within scope.
- Lead and oversee training activities and adherence to standard operating procedures.
- Provide technical guidance to team members.
- Assist with creating and reviewing manufacturing procedures and documentation used in the GMP manufacturing lab.
- Initiate and execute quality system documentation, including Deviation and Nonconformance Reports, Customer Notifications, and Change Request Records.
- Use hazardous chemicals safely and adhere to the company PPE policy.
- Keep training up to date.
- Follow ISO 13485 quality management system requirements and applicable quality-contract terms.
Benefits
- Competitive compensation with a strong bonus program.
- Medical, dental, and vision benefits for employees and dependents.
- FSA/HSA pre-tax savings plans for health care, childcare, and elder care.
- Deductible Buffer Insurance and Critical Illness Insurance.
- 401(k) retirement plan with matching employer contribution.
- Company-paid short- and long-term disability, life insurance, and employee assistance program.
- Flexible work options.
- Pet insurance.
- Eight weeks of parental leave for qualifying life events.
- PTO that begins immediately.
- Monthly town hall meetings, employee recognition program, company-wide social events, and frequent catered lunches.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
