Shift Lead (Crosslink): 2nd Shift M-F 10am-6:30pm
Anika
August 18, 2026
On-site
Bedford, MA
$33.65 - $43.26 USD yearly
Operations
What You’ll Do / How You’ll Contribute
- Oversee day-to-day crosslink and aseptic manufacturing floor operations in a regulated cGMP environment, ensuring safety, quality, and production requirements.
- Provide direct floor leadership; coordinate and execute daily crosslink manufacturing (organic synthesis, purification, dissolution, formulation, filling, syringe sterilization) in controlled cleanrooms.
- Assign/prioritize work, resolve real-time production issues, and communicate schedule/supply needs.
- Ensure completion of MRP/ERP transactions; execute material receipt/consumption/production reporting in ERP.
- Review and verify GMP documentation (batch records, logbooks, forms) for accuracy/completeness/compliance; ensure GDP and data integrity.
- Initiate deviations/investigations/quality events; partner on root cause and corrective actions.
- Support training/mentoring of junior staff; provide performance feedback.
- Act as SME for critical processes; perform hands-on execution when required; ensure safe work practices and escalate safety risks.
What It Takes
- On-shift operational leader making real-time decisions that impact safety, quality, and delivery in a fast-paced, highly regulated environment.
What You Bring
- Bachelor’s degree in Engineering, Chemistry, Manufacturing, or related field (preferred) or equivalent experience.
- 6+ years cGMP manufacturing experience.
- 3+ years MRP system experience (production transactions/material tracking).
- 2+ years cGMP-regulated pharmaceutical/medical device Lead or similar role (training/mentoring).
- Strong knowledge of FDA, ISO, OSHA, and quality system requirements; strong written/verbal communication.
- Ability to work flexible hours.
Nice to Have
- Internal audit/inspection experience; cleanroom/aseptic technique; SAP (or similar ERP); Microsoft Office; strong organizational skills.
Benefits (as stated)
- Discretionary bonus; comprehensive healthcare, HSA; 401(k) with up to 5% match; employee stock purchase plan; accrued paid time off; long-term incentives (stock awards).
- Oversee day-to-day crosslink and aseptic manufacturing floor operations in a regulated cGMP environment, ensuring safety, quality, and production requirements.
- Provide direct floor leadership; coordinate and execute daily crosslink manufacturing (organic synthesis, purification, dissolution, formulation, filling, syringe sterilization) in controlled cleanrooms.
- Assign/prioritize work, resolve real-time production issues, and communicate schedule/supply needs.
- Ensure completion of MRP/ERP transactions; execute material receipt/consumption/production reporting in ERP.
- Review and verify GMP documentation (batch records, logbooks, forms) for accuracy/completeness/compliance; ensure GDP and data integrity.
- Initiate deviations/investigations/quality events; partner on root cause and corrective actions.
- Support training/mentoring of junior staff; provide performance feedback.
- Act as SME for critical processes; perform hands-on execution when required; ensure safe work practices and escalate safety risks.
What It Takes
- On-shift operational leader making real-time decisions that impact safety, quality, and delivery in a fast-paced, highly regulated environment.
What You Bring
- Bachelor’s degree in Engineering, Chemistry, Manufacturing, or related field (preferred) or equivalent experience.
- 6+ years cGMP manufacturing experience.
- 3+ years MRP system experience (production transactions/material tracking).
- 2+ years cGMP-regulated pharmaceutical/medical device Lead or similar role (training/mentoring).
- Strong knowledge of FDA, ISO, OSHA, and quality system requirements; strong written/verbal communication.
- Ability to work flexible hours.
Nice to Have
- Internal audit/inspection experience; cleanroom/aseptic technique; SAP (or similar ERP); Microsoft Office; strong organizational skills.
Benefits (as stated)
- Discretionary bonus; comprehensive healthcare, HSA; 401(k) with up to 5% match; employee stock purchase plan; accrued paid time off; long-term incentives (stock awards).