Associate Director, LNP Process Development

Recipharm AB; Sundsvalls kommun; On-site; SEK 1,447,876 - 2,027,027; Full time

Job summary

Recipharm AB in Watertown, MA seeks an Associate Director, LNP Process Development to define and steer robust Lipid Nanoparticle manufacturing processes. You will lead process design, optimization, tech transfer, and cross‑functional collaboration to support multiple programs.

The role requires a scientific leader who can manage a team, drive QbD for LNP programs, and provide technical input to customers while shaping nucleic acid process science platforms.

Qualifications

• Master’s degree in Biochemical Engineering, Chemistry, Biological Sciences, or related field.
• 6 years of experience in process development and analytical characterization for nucleic acid non-viral delivery; includes cGMPs for LNP production.
• Alternative: PhD and 3 years of the stated experience.

Responsibilities

• Responsible for technical and team leadership with proficiencies in LNP process development, scale-up & tech transfer to support a multi-product/customer development organization
• Design, plan, and execute experiments to develop, understand, and characterize processes for LNP production
• Lead and oversee LNP process transfers and technical project plans to and from internal and external business partners
• Support analytical development and quality team to establish LNP characterization capacities, build up & execute Quality by Design (QbD) for LNP programs
• Provide key input into the development of company’s nucleic acid process science platforms and novel technologies
• Support the commercial function in the assessment of new opportunities and provide appropriate technical and programmatic input to prospective customers, including the demonstration of capability at customer visits

Skills

LNP process development

Tech transfer

Scale-up

Quality by Design

Education

Master’s degree in Biochemical Engineering, Chemistry, Biological Sciences, or related field

PhD with 3 years of relevant experience (alternative)

Job description

Associate Director, LNP Process Development

Reporting to the VP, Head of Process Development, this role will define and steer the development and implement robust clinical/commercial LipidNanoparticles (LNP) manufacturing processes. The Associate Director should be a scientific leader and proficient in state-of-the‑art techniques for process design and optimization of LNP process and related characterization. Will provide direct leadership for the LNP process sciences team, is a key member of the nucleic acid process science organization and is a key value stream leader for customer projects. Job duties include:

Responsibilities

• Responsible for technical and team leadership with proficiencies in LNP process development, scale‑up & tech transfer to support a multi-product/customer development organization
• Design, plan, and execute experiment to develop, understand, and characterize processes for LNP production
• Lead and oversee LNP process transfers and technical project plans to and from internal and external business partners.
• Support analytical development and quality team to establish LNP characterization capacities, build up & execute Quality by Design (QbD) for LNP programs
• Provide key input into the development of company’s nucleic acid process science platforms and novel technologies
• Support the commercial function in the assessment of new opportunities and provide appropriate technical and programmatic input to prospective customers, including the demonstration of capability at customer visits.

Qualifications

Must have Master’s of Science degree in Biochemical Engineering, Chemistry, Biological Sciences, or a related field

Must have 6 years of experience working with process development and analytical characterization for nucleic acid non‑viral delivery. The stated experience must include the following:

• Process development, tech transfer and scale‑up experience in cGMPs related to LNP production
• Working with customers in product development related to LNP production

Alternatively, we will accept a PhD and 3 years of the stated experience.

Schedule

Full‑time

Shift: Report to the main office in Watertown, MA.