Oligo Manufacturing Lead - Swing shift

LGC Group•Petaluma, CA

10h•Onsite

About The Position

The Oligo Manufacturing Lead works directly with the departmental Supervisor and Manager to ensure that departmental functions in the GMP Manufacturing Lab comply with company procedures and external regulatory requirements. The role performs and supports GMP oligonucleotide manufacturing, operates instruments in the work area, helps the team meet performance objectives, and supports timely completion of product and process quality activities. The lead provides technical guidance, oversees training and SOP adherence, assists with manufacturing procedures and documentation, and initiates and executes quality-system records. The position also requires safe daily use of hazardous chemicals and compliance with the company’s PPE policy. The posting identifies a swing-shift role; core hours depend on the production lab and shift, and overtime may be required with manager pre-approval. No travel is required.

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.
Mathematical ability to add, subtract, multiply, and divide units of measure using whole numbers, common fractions, and decimals.
Computer skills, including Microsoft Office, Outlook, Word, Excel, and web browsers.
Self-motivation and 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 approach tasks methodically.
Strong communication and problem-solving abilities.
Ability to meet the normal physical demands of a laboratory environment.

Nice To Haves

Experience with or knowledge of instrumentation such as HPLC, MS, Purifiers, Spectramax, SpeedVacs, Liquid Handlers, TFF, and pipettes.
Knowledge of Unicorn and Empower.

Responsibilities

Learn and follow ISO 13485 quality-management-system requirements and the terms of the quality contract.
Perform or support departmental GMP oligonucleotide manufacturing functions according to established procedures.
Operate and manufacture product on 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 activities.
Recognize equipment or documentation issues and take appropriate corrective action within the role’s 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 for 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 in the manufacturing environment and adhere to the company PPE policy.
Keep training up to date.

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.