Lead Formulation Development

JOB DESCRIPTION

Designation: Lead Formulation Development

Job Location: Bangalore

The Company

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key Result Areas

Role-specific:

• Develop and optimize sterile injectable formulations for biologics, including liquid and lyophilized dosage forms.
• Design and execute pre-formulation studies, excipient compatibility assessments, forced degradation and stability studies.
• Drive early and late-stage formulation development and support transition from preclinical to clinical and commercial.
• Collaborate with clinical operations to design and execute in-use compatibility studies.
• Design and execute formulation characterization studies.

• Execute technology transfer to pilot-scale, clinical and commercial manufacturing sites.
• Collaborate with CMC, process development, and manufacturing teams to develop commercial formulations.
• Prepare and review regulatory documents (IND, BLA, IMPD, etc) to support clinical and commercial filings.
• Ensure compliance with cGMP, ICH, FDA and EMEA guidelines for formulation and process development.
• Work closely with analytical development, quality assurance, and regulatory teams to ensure successful formulation development.
• Mentor and provide scientific/technical guidance to junior scientists and external partners.

Education and Experience

Education

PhD or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.

Industry Experience

• We are seeking an experienced Drug Product Formulation to lead formulation development for sterile injectable products, including liquid and lyophilized formulations. The ideal candidate should have experience in the biopharmaceutical industry, with expertise in early- and late-stage formulation development, process characterization, scale-up and technology transfer. This role will focus on designing robust drug product formulations, scaling up manufacturing processes, executing process validation lots and authoring regulatory submissions. He/she will work in close collaboration with the Head of Biologics Development to drive the project milestones.

Other competencies required for the role

• Experience in biologics formulation development with a focus on sterile injectables.
• Demonstrated capability in DoE, QbD and risk-based approaches to formulation and process development.
• Strong knowledge of lyophilized and liquid formulation principles of complex biologics including fusion and bispecific molecules.
• Experience with early- and late-stage drug product development, scale-up, formulation/process characterization, PPQ, commercial manufacturing and life-cycle management.
• Familiarity with HPLC, DSC, particle size analysis and biophysical techniques applied for biologics drug formulation development and characterization.
• Excellent ability to troubleshoot formulation challenges, and drive investigation studies to create robust and scalable processes. 
• Strong interpersonal skills with ability to work with internal and external stakeholders.
• Excellent written and verbal communication skills for regulatory documentation and presentations.

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Pls visit us at https://syngeneintl.com/ to know more about us and what we do.