Manager -1 Biotechnology

SUN PHARMA; Madhya Pradesh; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Sun Pharma seeks a Manager - Biotechnology to lead bioanalytical assay development in collaboration with CROs. The role requires oversight of TK, PK, ADA and NAB assays in regulated GLP/GCLP settings, and guidance on regulatory content.

Qualifications include M.Pharm/M.Sc/M.Tech and 9+ years of experience. Location is Vadodara; department is R&D1 Regulatory Affairs. You will interact with SMEs and manage external partnerships to advance pre-clinical and clinical studies.

Qualifications

• M.Pharm/M.Sc/M.Tech is required.
• 9+ years of relevant experience is expected.
• Experience in bioanalytical services within regulated GLP/GCLP environments.

Responsibilities

• Work with CROs for bioanalytical assay development.
• Lead TK, PK, ADA & NAB assay development and validation at CROs in GLP/GCLP environments.
• Lead evaluation of innate immune responses for therapeutic peptides and proteins.
• Lead assessment of adaptive immune responses for therapeutic peptides and proteins.
• Represent bioanalytical at project teams; provide oversight of CRO activities including reagent generation, assay development and validation.
• Collaborate with SME representatives in clinical and non-clinical groups.
• Identify and screen CROs for bioanalytical services.
• Guide CROs on assay development, experimental design, troubleshooting and sample analysis.
• Review method development reports, validation reports and ATPs.
• Draft technical content for regulatory dossiers.

Skills

Bioanalytical assay development

TK assay development

PK assay development

ADA assay development

NAB assay development

GLP/GCLP environment

CRO management

Regulatory queries handling

Education

M.Pharm/M.Sc/M.Tech

Job description

Job Description:

Job Title: Manager - Biotechnology

Business Unit: R&D1 Regulatory Affairs

Job Grade: G10

Location: Vadodara

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.

Key Responsibilities

• Work in close partnership with contract research organizations (CROs) for Bio analytical assay development.


• Responsible for TK, PK, ADA & NAB assay development, validation at external contract organizations (CROs) in a regulated (GLP, GCLP) environment to support pre-clinical and clinical studies.


• Lead the evaluation of innate immune responses associated with therapeutic peptides and proteins.


• Lead the assessment of adaptive immune responses associated with therapeutic peptides and proteins


• Serve as the bioanalytical representative at project team meetings and provide scientific and operational oversight of bioanalytical activities conducted at CROs including reagent generation, assay development and validation.


• Work independently and in collaboration with a subject matter expert (SME) representative of the clinical & non-clinical group.


• Identification & screening of CROs for Bioanalytical services.


• Provide guidance to contract organizations (CROs) on assay development, experimental design, troubleshooting and sample analysis.


• Review of method development reports (MDRs), validation reports and bio analytical test procedures (ATPs).


• Responsible for managing the regulatory queries.


• The candidate is expected to draft the technical content for regulatory dossier.

Travel Estimate: NA

Job Requirements

Educational Qualification

M.Pharm/M.Sc/M.Tech

Experience

• More than 9 years of relevant experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!