Lead Scientist DP Formulation

JOB DESCRIPTION

Job Title: Lead Scientist DP Formulation – Large Molecule

Job Location: Bengaluru

Department: Formulation Development

About Syngene:  Syngene (www.syngeneintl.com) 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 company’s 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 integrity, health, 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:

• Responsible for product & formulation development for large molecular parenteral drug products (protein, biosimilar, biological etc.) which includes  formulation screening, FDS screening, formulation design, process optimization & characterization, and technology transfer from R&D to different manufacturing sites.
• Lead all activities for transferring lab process to GMP manufacturing site and facilitate drug product manufacturing in GMP fill finish facility, in coordination with production and quality team.

• Responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials

Role Accountabilities

• Hold self-accountable for the achievement of client milestone.
• Meet Compliance related expectation

Leadership Capabilities

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience in formulation development and technology transfer of large molecule parenteral drug products (protein, biosimilar, biological etc.) 

2. Demonstrated Capability:
   1. Experience in biologics formulation development, biosimilars, analytical characterization, technology transfer, and commercial manufacturing support.
   2. Strong exposure to global regulatory filings and commercialization of biosimilar and innovative biologics products.
   3. Experience working with CDMOs and global manufacturing networks will be highly desirable.

3. Education: M Pharm Pharmaceutics / Master in Biotechnology 

Skills and Capabilities

• Must have significant experience in large molecule (biologics) drug product formulation and process development, supporting programs from preclinical and clinical development through commercialization.
• Demonstrated expertise in the development of biosimilars, recombinant proteins, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), fusion proteins, peptides, and novel biologics.
• Strong understanding of formulation strategies for biologics including:  Excipient selection and optimization, Protein stabilization mechanisms, Aggregation control, Oxidation and deamidation mitigation, Freeze-thaw stability, Container closure compatibility
• Strong understanding of Protein manufacturing (upstreaming)  and  purification processes (down streaming) and established record for working closely with downstream team
• Extensive experience in reference product characterization, de-formulation, biosimilar analytical similarity assessment, and comparability studies to support biosimilar development programs.
• Hands-on experience in formulation development and scale-up of: Liquid formulations, Lyophilized formulations, High-concentration biologic formulations suitable for subcutaneous administration

• Expertise in the selection, characterization, and qualification of primary packaging systems including Vials, Prefilled syringes (PFS), Cartridges, Autoinjectors etc. along with associated regulatory expectations for US, EU, and global markets.
• Strong knowledge of protein analytical characterization techniques, including SEC-HPLC, CE-SDS, icIEF, IEX, HIC, RP-HPLC, ELISA, Binding assays, Bioassays, DLS, DSC, Particle characterization techniques.

• Thorough understanding of regulatory expectations for biosimilarity assessment, product comparability, and analytical similarity evaluations.
• Good understanding of process engineering principles and scale-dependent parameters required for successful transfer of biologics drug product manufacturing processes across development, pilot, and commercial scales.
• Hands-on experience in: Technology transfer activities, Process characterization, Process validation, Continued Process Verification (CPV), Process troubleshooting and root cause investigation.
• Expertise in development and optimization of Sterile filtration processes, Filter compatibility studies, Filter adsorption assessment, Filter validation studies for protein products
• Expertise in diafiltration, ultrafiltration, dialysis techniques with respect to large molecule
• Strong working knowledge of aseptic processing and manufacturing operations for biologics drug products.
•  Expertise in design, development, optimization, and scale-up of lyophilization cycles for proteins, monoclonal antibodies, and other biologics, including characterization using thermal analytical techniques.
•  Experience working in GMP-regulated environments with focus on: Data integrity, Compliance, Documentation practices, Health, safety, and environmental requirements

• Strong scientific skills for interpretation of analytical and process data, defining product critical quality attributes (CQAs), and making data-driven decisions.
• Experience authoring and reviewing technical reports, development reports, technology transfer documents, risk assessments, validation protocols, and regulatory supporting documentation.
• Work closely with Manufacturing, Quality Assurance, Quality Control, Validation, Regulatory Affairs, and Engineering teams, as well as external CDMOs/CMOs, to ensure successful process scale-up and site technology transfers.
• Good understanding of phase-appropriate GMP quality systems and clinical trial material supply requirements across different stages of development.
• Experience preparing, reviewing, and supporting GMP documentation.
• Working knowledge of quality management systems and deviation management, including’s investigations, OOT investigations, CAPA management, Change control, Risk assessments etc.
• Strong understanding of ICH, FDA, EMA, and global regulatory requirements related to biologics drug product development, technology transfer, process validation, and lifecycle management.
• Strong analytical thinking and risk assessment capabilities with proven ability to identify critical technical issues and implement effective mitigation strategies.
• Excellent communication, stakeholder management, and cross-functional leadership skills for driving complex development and technology transfer programs.
• Ability to effectively manage multiple projects, prioritize activities, and collaborate with functional and project management teams to achieve timelines, milestones, and business objectives.

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.