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
Lead the Analytical and Characterization strategy for late-stage clinical and commercial programs, ensuring assays are fit-for-purpose for validation and regulatory submission.
Oversee the design, development, optimization, and qualification of in-process, lot release, biophysical and MS methods to support product release and characterization.
Accountable for defining analytical study plan including, method development, in-process analytics, stage-wise testing for Cell Line/Bioprocess/Formulation development in consultation with client and cross-functional teams
Partner closely with CMC, Quality, Regulatory, and Manufacturing teams to ensure seamless assay transfer, validation, and lifecycle management.
Serve as the subject matter expert in regulatory interactions, authoring and reviewing CMC sections of INDs, BLAs, and other submissions.
Execute data analysis, create technical reports and co-ordinate project execution with cross-functional teams
Manage and mentor a high-performing team of scientists, fostering technical excellence, innovation, and professional growth.
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Drive continuous improvement in method robustness, throughput, and compliance with ICH and USP guidelines.
Collaborate with external partners, CROs, and contract manufacturers to ensure assay consistency across global sites.
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Experience
Experience in biologics (preferably mAbs and fusion biologics) development with a focus on sterile injectables.
Proven track record in Analytical and Characterization method development, technology transfer and validation.
Strong knowledge of structure-function assays of complex biologics including fusion and bispecific molecules.
Experience supporting with early- and late-stage drug development, PPQ, commercial and life-cycle management.
Excellent ability to troubleshoot OOS, and drive investigation studies to create robust analytical methods.
Strong interpersonal skills with ability to work with internal and external stakeholders.
Excellent written and verbal communication skills for regulatory documentation and presentations.
Education
Ph.D. or equivalent in Biology, Biochemistry, Immunology, or related field, with relevant industry experience in Analytical and Characterization Assay Development.
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 accommodation for qualified individuals with disabilities.
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