Lead Formulation Development

JOB DESCRIPTION

Job Title: Lead Formulation Development

Job Location: Bangalore

Department: Biopharmaceutical Development

About Syngene: Syngene () is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures practices and systems that ensures safe operations and compliance to companys integrity & quality standards
• Driving a corporate culture that promotes environment health and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self teams and lab/plant by adhering to safety protocols and following environment health and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrityhealth and safety measures are completed on time by all members of the team including self
• Compliance to Syngene s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role

• 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.

Role Accountabilities

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.

Leadership Capabilities

• Innovation & Problem-Solving Lead formulation design and troubleshoot challenges.
• Operational Excellence Deliver projects on time within cost and with quality.
• Stakeholder Management Coordinate with leadership partners and regulators.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

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.

Skills and Capabilities

Drug Product Formulation lead formulation development for sterile injectable products including liquid and lyophilized formulations.

Education

PhD or Masters degree in Pharmaceutical Sciences Chemical Engineering Biotechnology or related field.

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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.