Formulation and Fill Finish Specialist

Iksuda Therapeutics is a Biotechnology Company focussed on the development of Antibody Drug Conjugates (ADCs) targeting difficult-to-treat cancers.

We are looking for a Formulation and Fill Finish Specialist to join our Development Team. You will be responsible for supporting acceleration of lead candidate molecules through Development. This includes planning and oversight of formulation and fill finish development work packages; working with CMOs to design formulation and fill finish development and qualification/validation strategies; performing technical appraisal of data against acceptance criteria and study parameters; technology transfer; IND/IMPD authoring and reviewing; representing the CMC Development function as a Subject Matter Expert (SME) on internal & external project teams.

Personnel skills include:

• In depth knowledge relating to formulation development, both liquid and lyophilized, of antibody drug conjugates and unconjugated antibodies
• In depth understanding of fill finish of sterile, injectable products and strong regulatory knowledge (EU and US focused)
• Proven ability to design phase appropriate assays and stability programs, including Clinical In Use, to probe the critical quality attributes of antibody drug conjugates and ensure manufacturing consistency and patient safety
• Excellent documentation and organizational skills
• Able to communicate effectively at all levels with internal employees and external clients, and with the ability to work collaboratively as a member of cross-functional and global team

Essential Functions and Duties

• Planning and oversight of formulation and fill finish development work packages
• Technical appraisal of data against acceptance criteria and study parameters
• Contribution to the product target development profile, quality target product profile, pharmaceutical development plan, manufacturability and developability assessment
• Partnering and building relationships with CDMOs and other service providers
• Representation of CMC function at internal and external meetings
• IND/IMPD authoring and reviewing
• Actively collaborate with Non-Clinical, Clinical, Regulatory, QA, R+D, Operations, Business Development, Legal and Program Management
• Supporting Business Development in due diligence programs

Education and Experience

• An MSc (or equivalent) in Biochemistry, Biophysics, Protein Engineering, Structural Biology or related field and a minimum of 8 years of industry experience, ideally with 5-8 years in the biotechnology industry
• A PhD (or equivalent) Biochemistry, Biophysics, Protein Engineering, Structural Biology or related field with a minimum of 5 years of industry experience, ideally with 5-8 years in the biotechnology industry

Knowledge, Skills, and Abilities

• Minimum of 3 years’ experience of working in the ADC field
• Solid knowledge and hands-on experience in biotechnology/pharmaceutical product development including process and analytical development, stability studies, etc.
• Experience working within a CMC organization and knowledge of regulatory issues related to biologics quality
• Ability to independently manage job priorities
• Excellent written and presentation skills in English

Salary negotiable depending on experience.

Predominantly working remotely with visits to the Company’s UK and US facilities and vendor sites as appropriate.

Job Type: Full-time

Salary: £40,000.00-£60,000.00 per year

Schedule:

• Monday to Friday

Education:

• Master's (required)

Work Location: Remote

Reference ID: IKS/CMC02