Join Auxilla Pharmaceuticals and Research LLP, an innovative formulation development company based in Ahmedabad, Gujarat, specializing in 505(b)(2) and IND-based incremental innovation. We’re hiring a Senior Research Associate for our Analytical Development (AD) Department to support our work in injectables, ophthalmics, semi-solids, and nanotechnology-based platforms like liposomes and microspheres, backed by a PE-supported public listed company.
Job Details: Senior Research Associate – Analytical Development
We’re seeking a skilled professional with 4-6 years of experience in analytical development for our Ahmedabad facility, a hub for advanced pharmaceutical formulation development compliant with USFDA standards.
Position
- Senior Research Associate
Department
- Analytical Development (AD)
Qualification
- M.Sc. (Analytical Chemistry, Organic Chemistry) or M.Pharm (Pharmaceutical Analysis, Pharmaceutics)
Experience
- 4-6 years in analytical development, preferably in formulation R&D for injectables or semi-solids
- Must have hands-on experience in method development and validation
Job Location
- Onsite: Auxilla Pharmaceuticals and Research LLP, 5001-5002, 5th Floor, Prerna Aartika, Ahmedabad-Sanand-Viramgam Highway, Village Sanand, Ahmedabad, Gujarat – 382110
Key Responsibilities
- Analytical Testing:
- Perform assay, dissolution, and related substances (RS) testing for formulations (e.g., injectables, ophthalmics)
- Operate and maintain analytical instruments: HPLC, GC, UV-Vis, IR, KF titrator, and pH meter
- Conduct stability studies and routine sampling per ICH guidelines
- Method Development & Validation:
- Develop and validate analytical methods for assay, dissolution, and RS as per USP and ICH Q2
- Prepare protocols, validation reports, and SOPs compliant with CGMP
- Handle method transfers to Quality Control teams
- Documentation & Compliance:
- Maintain accurate records per Good Laboratory Practices (GLP)
- Support USFDA and EUGMP audits with analytical data
- Investigate OOS and OOT results
- Instrument Calibration:
- Perform daily calibration of HPLC, GC, UV, IR, KF, and pH meters per schedule
- Ensure equipment hygiene and compliance with USP-NF ⟨1058⟩ for analytical instrument qualification
Key Skills
- Proficiency in operating HPLC (Waters, Shimadzu), GC (Agilent), UV-Vis, IR, KF titrator, and pH meter
- Expertise in analytical method development and validation for assay, dissolution, and RS
- Strong knowledge of CGMP, GLP, and ICH Q3 guidelines
- Experience with injectables or semi-solid formulations (e.g., liposomes, microspheres)
- Familiarity with QMS (e.g., deviations, CAPA) and analytical data review
- Analytical problem-solving and documentation skills
Number of Openings
- 1 (based on single position advertised)
Why Join Auxilla Pharmaceuticals?
Founded in 2020 by Manish Umrethia and Suchiben Patel, Auxilla Pharmaceuticals is a dynamic formulation R&D company with a team of 64+ professionals, growing 3.2% year-on-year as of July 2024. Our Ahmedabad facility, supported by Shilpa Medicare ($7.91M investment), focuses on novel drug delivery systems, earning a 4.0/5 rating for innovation-driven culture.
Key Benefits
- Work in a USFDA-compliant R&D facility with cutting-edge nanotechnology platforms
- Collaborate on 505(b)(2) projects for global markets
- Engage in employee-centric events like cricket tournaments and Women’s Day celebrations
- Opportunities for career growth in a PE-backed, fast-growing organization
- Access to Disso India Ahmedabad 2024 insights for dissolution science advancements
How to Apply
Interested candidates should:
- Email updated CV to hr@auxillapharma.com with subject “Sr. Research Associate – AD – Ahmedabad”
- Include educational certificates (M.Sc., M.Pharm), experience letters, and ID proof (Aadhar, PAN)
- Be prepared to discuss hands-on experience with HPLC, method validation, and CGMP compliance
- Note: Auxilla Pharmaceuticals does not charge fees or request sensitive information during recruitment. Verify communications via official @auxillapharma.com emails.
Documents to Bring (if attending future walk-ins)
- Resume
- Photocopy of educational certificates
- Latest increment letter
- Last 3 months’ payslips
- Last 6 months’ bank statements
- Passport-size photographs
- Aadhar card copy
Verified by Trusted HRs
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About Auxilla Pharmaceuticals and Research LLP
Auxilla Pharmaceuticals, established in 2020, is headquartered in Ahmedabad, Gujarat, with a registered capital of ₹150M. We specialize in injectables, ophthalmics, semi-solids, and liquid orals, leveraging nanotechnology for advanced drug delivery. Certified by FDCA and aligned with GMP, our facility supports global regulatory submissions. With 7,420+ LinkedIn followers, we foster a collaborative culture, recognized for employee engagement and innovation.
Our Mission
- Drive 505(b)(2) innovation in drug delivery
- Ensure quality through CGMP and regulatory excellence
- Build a vibrant, inclusive workplace for scientific advancement
Apply by emailing hr@auxillapharma.com to join Auxilla Pharmaceuticals in Ahmedabad. Contribute to innovative formulation development and advance healthcare! Visit www.auxillapharma.com for more details.