Senior Executive

2 days ago

Tandalja, India SUN PHARMA Full time

Key Responsibilities: Analytical Method Development & Validation Develop and validate robust HPLC methods for characterization and quantification of biological products (e.g., monoclonal antibodies, recombinant proteins). Perform method optimization, robustness studies, and transfer protocols as per ICH guidelines. Routine & Stability Testing Conduct analysis of in-process, release, and stability samples using: HPLC/UPLC Capillary and Gel Electrophoresis UV spectrophotometric methods Host Cell DNA quantification (e.g., qPCR-based methods) HCP ELISA and other immunoassays Instrument Operation & Maintenance Perform routine maintenance, calibration, and troubleshooting of analytical instruments including HPLC, electrophoresis systems, spectrophotometers, and ELISA readers. Ensure timely qualification and performance verification of instruments. Documentation & Compliance Prepare and review SOPs, STPs, protocols, reports, and analytical records in compliance with regulatory requirements. Maintain accurate and complete documentation in laboratory notebooks and electronic systems. Quality & Regulatory Compliance Participate in internal and external audits, and support regulatory submissions with analytical data. Cross-functional Collaboration Work closely with R&D, Quality Control, and Regulatory Affairs teams to support product development and lifecycle management. Provide technical support during investigations, deviations, and CAPAs. Training & Development Train junior analysts and new team members on analytical techniques and laboratory practices. Stay updated with advancements in analytical technologies and regulatory expectations. Qualifications & Experience: M.Sc. / M.Tech / M.Pharm in Biotechnology, Biochemistry, or related life sciences discipline. 4–8 years of relevant experience in analytical development or QC of biopharmaceuticals. Hands-on experience with HPLC method development and ELISA based techniques. Familiarity with regulatory guidelines (ICH, FDA, EMA) and quality systems. Key Skills: Strong analytical and problem-solving skills Attention to detail and data integrity Excellent documentation and communication abilities Proficiency in software tools like Empower, Chromeleon, SoftMax Pro, etc. Ability to manage multiple projects and meet deadlines

  • Senior Executive- Pharmacokinetics

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Senior Executive - Pharmacokinetics Business Unit: R&D1 Regulatory Affairs Job Grade G11B Location : Baroda 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?...

  • Executive - Analytical Development

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Senior Executive /Executive – Analytical Development Business Unit: R&D1 Regulatory Affairs Job Grade G12A/G11B Location : Baroda 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.

  • Senior Executive

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Executive – API R&D Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location : Baroda 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...

  • Senior Executive/ Manager 2

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Senior Executive / Manager 2 – Analytical Development (LCMS) Business Unit: R&D1 Regulatory Affairs Job Grade G11B/G11A Location : Baroda 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...

  • Executive - FRD Non-Orals

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Senior Executive / Executive – FRD Non-Orals Business Unit: R&D1 Regulatory Affairs Job Grade G11B / G12A Location: Baroda 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...

  • Senior Executive

    2 weeks ago

    Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries, Inc. Full time ₹ 1,20,000 - ₹ 1,80,000 per year

    Title: Senior Executive - Analytical DevelopmentDate: Oct 15, 2025Location: Tandalja - R&DCompany: Sun Pharmaceutical Industries LtdJob Title:Sr. Executive/Execyutive – Analytical DevelopmentBusiness Unit:R&D1 Regulatory AffairsJob GradeG11B/G12ALocationBarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment...

  • SENIOR MANAGER

    2 days ago

    Tandalja, India SUN PHARMA Full time

    ·Designing, executing and interpreting bioassays/pharmacological studies. Knowledge of GLP/GMP. ·Leading and managing in-vitro/in-vivo projects, ensuring timely completion ·Mentoring junior scientists, building and leading cross functional teams ·Analyzing data, preparing reports and presenting to stakeholders · Collaborating with other departments, to...

  • Executive - Regulatory & Business Continuity

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Senior Executive /Manager 2 – Regulatory Affairs Business Unit: R&D1 Regulatory Affairs Job Grade G11A/G11B Location : Baroda 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...

  • Senior Executive

    2 days ago

    Tandalja, India SUN PHARMA Full time

    To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to align with organization goal and other responsibilities assigned by reporting authority. Responsible to perform the calibration of instrument and to maintain instrument/equipment as per SOPs. Responsible to follow safety precaution as per laboratory procedure....

  • Senior Manager

    2 days ago

    Tandalja, India SUN PHARMA Full time

    1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support...