Oligonucleotide Steward & Process Transfer Lead

BioSpace; Houston (TX); Vor Ort; USD 131.000 - 211.000; Vollzeit

Benefits dieser Stelle

401(k)

Pension

Vacation benefits

Medical insurance

Dental

Vision and Rx benefits

Flexible benefits

Life insurance

Time off and leave

Zusammenfassung

Lilly is constructing an advanced manufacturing facility in Houston, TX for API production, seeking experts to lead oligonucleotide stewardship and site transfer for commercial molecules. The role interfaces with engineering, manufacturing, quality, development, and regulatory teams to enable GMP manufacturing readiness.

Qualified candidates will have a strong cGMP background, 10+ years in API manufacturing, and proven leadership in process validation and transfer activities.

Qualifikationen

• Bachelor's degree required in Chemistry, Microbiology, Biochemistry, Biochemical engineering or a related science field.
• Minimum of 10 years of experience in cGMP oligonucleotide, peptide, or small molecule API commercial-scale manufacturing.
• Masters or PhD preferred.
• Process validation, cleaning validation, and commercialization experience a plus.
• Demonstrated leadership skills.
• Excellent communication skills, both oral and written.
• Process and equipment knowledge of chemical synthesis active pharmaceutical ingredients.
• Thorough understanding of cGMP requirements for a large-scale manufacturing facility.

Aufgaben

• Provides technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility.
• Leads technical transfer of processes between facilities and addresses scale-up issues.
• Mentors Process Team members and analyzes production data to support daily operations.
• Writes technical reports and reviews manufacturing documentation.
• Supports start-up and validation of new facilities and equipment in Houston.
• Leads or assists in process validations and change controls as needed.

Kenntnisse

Leadership skills

Communication skills

cGMP knowledge

Ausbildung

Bachelor's degree in Chemistry, Microbiology, Biochemistry, Biochemical engineering or related science field

Jobbeschreibung

Lilly is constructing an advanced manufacturing facility in Houston, TX for API production, seeking experts to lead oligonucleotide stewardship and site transfer for commercial molecules. The role interfaces with engineering, manufacturing, quality, development, and regulatory teams to enable GMP manufacturing readiness.

Qualified candidates will have a strong cGMP background, 10+ years in API manufacturing, and proven leadership in process validation and transfer activities.