Manufacturing Head - Biologics

- The position will provide oversight for biologics manufacturing projects to support clinical and commercial production and ensure timely and successful GMP transition and transfer across sites.

- The position will work with quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities.

- Prior experience working with and managing activities at CMOs is a plus

- Prior exposure and experience related to Global Biologics / Biosimilars development programs (Monoclonal Antibodies & Other complex recombinant proteins) will be considered an advantage

a) Conduct commercial capacity planning for programs in late stage development, in order to allow optimal supply chain with enhanced security during launch time and the subsequent commercialization.

b) Oversee and review metrics and key performance indicators of each manufacturing site.

c) Support implementation of necessary improvement to achieve high manufacturing efficiencies.

d) Coordinate biologics production schedules based on Product demand; communicate risks and delays to project teams on a timely basis.

e) Monitor and ensure that performance standards for cGMP compliance, product quality and production are consistently met.

f) Participate in preparation, review and approval of CMC sections of regulatory filings and act as process design SME during regulatory inspections

g) Perform other duties as assigned by Executive Management.

- Subject Matter Expert (SME) in either upstream or downstream Process Development, Scale-up and Process Characterization of recombinant biologics

- In-depth understanding of cGMP manufacturing of clinical and commercial biopharmaceutical proteins

- Current knowledge with regard to cGMPs and associated regulatory regulations and ICH guidelines enforced by global authorities.

- Ability to prioritize and successfully manage complex and competing projects

- Excellent communication and organizational skills.

- Ability to proactively mitigate quality/regulatory risks

- Motivated team player with proven leadership abilities

MSc or PhD in Chemical/Biochemical Engineering, Biochemistry or Process Sciences with a minimum of 10 years for MSc or 8 years for a PhD of relevant experience in the bio/pharmaceutical industry