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Join Tiefenbacher Laboratories, a global leader in pharmaceutical innovation under the Tiefenbacher Group, pioneering healthcare since 1963. We’re hiring a Senior Executive or Assistant Manager for our Product Development – In Vitro-In Vivo Correlation (IVIVC) team at our state-of-the-art, USFDA-approved facility in Hyderabad, focusing on generic, value-added, and highly potent drug formulations.
Job Details: Sr. Executive/Asst. Manager – Product Development (IVIVC)
We’re seeking a skilled professional with 5-10 years of experience in IVIVC and product development to advance our Finished Dosage Form (FDF) portfolio, including tablets, capsules, and innovative delivery systems, at our GLP/GMP-compliant Hyderabad laboratory.
Position
- Senior Executive / Assistant Manager
Department
- Product Development – In Vitro-In Vivo Correlation (IVIVC)
Qualification
- M.Pharmacy (Pharmaceutics, Pharmaceutical Technology) or Ph.D. (Pharmaceutical Sciences)
Experience
- 5-10 years in IVIVC, product development, and clinical studies
- Hands-on experience with IVIVC simulation tools (e.g., WinNonlin, GastroPlus)
Job Location
- Tiefenbacher Laboratories, Survey No. 42, Gaddapotharam, Kazipally Industrial Area, Sanga Reddy Dist., Hyderabad, Telangana – 502319
Contact
- Email: k.surendra@tiefenbacher.com
- Phone: +91-8418694444
Key Responsibilities
- IVIVC Development:
- Design and develop IVIVC models to correlate in vitro dissolution with in vivo pharmacokinetics
- Apply Level A, B, and C correlations to support bioequivalence and formulation optimization
- Product Development:
- Formulate FDFs (e.g., tablets, capsules, modified-release) for generic and highly potent drugs
- Conduct pre-formulation and formulation studies using advanced techniques (e.g., XRD Crystallography, Malvern particle size testing)
- Optimize formulations to meet QbD principles
- Clinical Studies:
- Support design and analysis of bioavailability/bioequivalence (BA/BE) studies
- Interpret pharmacokinetic data to establish IVIVC relationships
- Collaborate with CROs for clinical trial execution
- Simulation Tools:
- Operate IVIVC simulation software (e.g., WinNonlin, GastroPlus, DDDPlus)
- Perform deconvolution, convolution, and sensitivity analysis for IVIVC modeling
- Conduct nitrosamine testing and dissolution studies
- Documentation & Compliance:
- Prepare regulatory dossiers for USFDA, EMA, and other global submissions
- Maintain GLP/GMP-compliant records
- Support audits by USFDA, BGV (Germany), and TGA (Australia)
- Communication:
- Liaise with cross-functional teams (R&D, QA, RA) to align development goals
- Present IVIVC data and formulation strategies to internal and external stakeholders
Key Skills
- Expertise in IVIVC concepts and pharmacokinetic modeling
- Proficiency in simulation tools: WinNonlin, GastroPlus, DDDPlus
- Strong knowledge of QbD, BCS classification, and dissolution testing
- Experience in BA/BE studies and clinical pharmacokinetics
- Familiarity with GMP/GLP and regulatory guidelines
- Excellent communication skills for technical presentations and regulatory interactions
- Ability to work in a high-potent drug lab environment
Number of Openings
- 1 (based on single position advertised)
Why Join Tiefenbacher Laboratories?
Founded in 1963, Tiefenbacher Group is a family-owned healthcare pioneer with 800+ employees and a USD 53.3 million turnover, delivering 180+ FDFs across 10+ dosage forms, including highly potent drugs, to 500 million patients globally. Our Hyderabad facility, spanning 32,000 m², is equipped with cutting-edge technologies like XRD Crystallography and WinNonlin IVIVC tools, and was recently expanded with a high-potent drug block in 2023. Rated 4.0/5 for innovation on LinkedIn, we foster a culture of curiosity and excellence.
Key Benefits
- Work in a USFDA-approved, GLP/GMP-compliant R&D lab
- Contribute to generic and highly potent drug development for global markets
- Access advanced tools like WinNonlin and Malvern
- Engage in community initiatives, e.g., school building in Hyderabad
- Enjoy a low-turnover, family-oriented workplace with flexible arrangements
How to Apply
Interested candidates should:
- Email updated CV to k.surendra@tiefenbacher.com with subject “Sr. Executive/Asst. Manager – IVIVC – Hyderabad”
- Include educational certificates (M.Pharmacy, Ph.D.), experience letters, Aadhar card, and PAN card
- Be prepared to discuss:
- IVIVC modeling and simulation tools
- Product development for FDFs
- Experience with BA/BE studies and regulatory submissions
- Note: Tiefenbacher Laboratories does not charge fees or request sensitive information during recruitment. Verify communications via official @tiefenbacher.com emails.
Documents to Bring (if attending future walk-ins)
- Updated resume
- Educational certificates
- Experience letters
- Aadhar card and PAN card
- Last 3 months’ payslips (if applicable)
- Passport-size photographs
About Tiefenbacher Laboratories
Part of the Tiefenbacher Group, Tiefenbacher Laboratories in Hyderabad is a GLP/GMP-compliant R&D hub inspected by USFDA, BGV, Russian MIT, and Turkish MoH. Specializing in generic, value-added, and highly potent drugs, we develop 40+ products in our pipeline, including Rivaroxaban generics. Our Hyderabad site supports global launches with advanced technologies and a patient-centric approach.
Our Mission
- Make high-quality medicines affordable and accessible
- Pioneer healthcare through innovation and excellence
- Foster a collaborative, purpose-driven workplace
Apply by emailing k.surendra@tiefenbacher.com or calling +91-8418694444 to join Tiefenbacher Laboratories in Hyderabad. Shape the future of pharmaceutical innovation! Visit www.tiefenbachergroup.com for more details.