Senior Lead, MST & External Manufacturing

SARACA; Schaffhausen; On-site; CHF 140,000 - 190,000; Full time

Job summary

SARACA is seeking an experienced professional to lead biologics drug product development and technology transfer efforts in Schaffhausen. You will oversee scale-up and transfer activities, collaborate with CMOs, and ensure compliant, scalable manufacturing for clinical and potentially commercial programs.

The role requires strong problem-solving abilities, a track record in pharmaceutical manufacturing, and fluency in English with German a plus.

Qualifications

• Degree in Pharmaceutical, Biochemical, Life, Chemical or related sciences or comparable experience with 7+ years in pharma; PhD with 3+ years acceptable.
• Proven biologics drug product development experience in biopharma is an asset.
• Experience in biopharmaceutical process design is an asset.
• Solid understanding of technology transfer operations is preferred.
• Solid understanding of fill/finish operations is preferred.
• Experience in clinical or commercial manufacturing is required; prior CMO experience preferred.
• Proven track record of creativity and problem-solving.
• Ability to collaborate with cross-functional teams is essential.
• Excellent oral and written English skills; German is a plus.

Responsibilities

• Ensure timely plant readiness to support experimental and clinical activities.
• Ensure timely delivery of clinical material from internal pilot plants or CMOs.
• Manage the relationship with internal and external manufacturers, acting as single point of contact for each site.
• Provide pilot plant input and requirements to DPD and PCD.
• Support scale-up and technology transfer activities.
• Source raw materials and components and act as contact for material- and supplier-related issues at the CMO.
• Put in place the manufacturing information and capabilities for operations to produce DP in line with GxP, EHS and business requirements.
• Ensure manufacturing processes are consistent with platforms and transferable to commercial operations.
• Support investigations, CAPAs and change controls; perform critical raw data review of key documents.
• Assess new technologies and applications, covering feasibility, business case, conceptual design, installation and implementation.

Skills

Biologics development

Process design

Tech transfer

Fill/finish operations

Clinical/Commercial manufacturing

Creativity & problem-solving

Cross-functional collaboration

English (oral/written)

German language (nice to have)

Education

Degree in Pharmaceutical, Biochemical, Life, Chemical or related Sciences

Job description

• Ensure timely plant readiness to support experimental and clinical activities.
• Ensure timely delivery of clinical material from internal pilot plants or external contract manufacturing organizations (CMOs).
• Manage the overall relationship with internal and external manufacturers, acting as the single point of contact between the organization and each manufacturing site.
• Provide pilot plant input and requirements to Drug Product Development (DPD) and Primary Container Development (PCD).
• Support scale-up and technology transfer activities.
• Source raw materials and components as required, and act as the point of contact for material- and supplier-related issues at the CMO.
• Put in place the relevant manufacturing information and technical capabilities to enable the operations team to produce the drug product (DP) flawlessly, in line with GxP, EHS and business requirements.
• Ensure that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations.
• Support investigations, CAPAs and change controls according to assigned responsibilities, and perform critical raw data review of key documents.
• Assess new technologies and applications, covering feasibility, business case, conceptual design, installation and implementation.

Profile:

• Degree in Pharmaceutical, Biochemical, Life, Chemical or other relevant Sciences, or comparable experience, with a demonstrated track record of 7+ years in the pharmaceutical industry or a related field; alternatively, a PhD with 3+ years of proven experience.
• Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is an asset.
• Demonstrated proficiency and experience in biopharmaceutical process design is an asset.
• Solid understanding of, and experience in, technology transfer operations is preferred.
• Solid understanding of, and experience in, fill/finish operations is preferred.
• Experience in clinical or commercial manufacturing is required; prior experience working with a CMO is preferred.
• Proven track record of creativity and problem-solving.
• Ability to collaborate with cross-functional teams is a must.
• Excellent oral and written English skills; German is a plus.