Manager, Technical Services

What you'll do

• Execute process verification and cleaning validation, authoring protocols and reports and maintaining inspection-ready documentation.
• Lead technology transfers, process improvement, equipment troubleshooting, and root-cause investigations and CAPA; support qualification and regulatory inspections.
• Lead and develop the site's Technical Services team and coordinate its workload with site functions.

What they ask for

• Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related technical/scientific field.
• 5+ years of experience in pharmaceutical manufacturing or sterile/nonsterile compounding, with hands-on experience in process verification, cleaning validation, technology transfer, or equipment troubleshooting.
• Prior experience supervising or leading technical staff, including hiring, coaching, and performance management, in a regulated manufacturing or compounding environment.
• Working knowledge of USP <795>, <797>, and <800> (as applicable to site), FDA's Process Validation Guidance (2011), and cGMP requirements; experience supporting root-cause investigations and CAPA.

Nice to have

• Experience with peptide, oligonucleotide, or other complex API manufacturing processes.
• Hands-on experience with autoclaves, isolators, filling lines, or API processing/purification equipment; or experience supporting equipment commissioning, IOQ/PQ, site launches, or inspections.

Pay

$145K – $170K (USD, base salary)

Tools

USP <795>, USP <797>, USP <800>, FDA's Process Validation Guidance (2011), cGMP, CAPA, IOQ/PQ