Department: Analytical Development Lab (ADL)
Designation: ADL Sr. Officer/Executive
Experience: 3 to 4 Years
Location: Changodar, Ahmedabad
Employment Type: Full-Time, Permanent
Reporting To: ADL Manager / ADL Head
About the Role
We are seeking a detail-oriented and proactive ADL Scientist with a strong focus on documentation, regulatory communication, and formulation support to join our Analytical Development Laboratory. The candidate will serve as a key interface between the ADL team, formulation development department, and external clients. The role primarily demands excellence in technical documentation, protocol and action plan preparation, teleconference (T-Con) handling, and monitoring of ongoing analytical activities — rather than bench-level analytical work. The ideal candidate will be someone who can translate scientific discussions into structured documents and effectively coordinate between internal teams and clients under the guidance of the ADL Manager and HOD.
Key Responsibilities
A. Primary Responsibilities
- Prepare, review, and maintain all ADL-related documentation including method development reports, method validation reports, method transfer protocols, stability protocols, and analytical summaries in alignment with ICH, USFDA, EU GMP, and WHO guidelines.
- Draft and finalize Action Plans for ongoing and upcoming ADL projects; track timelines, document progress, and flag deviations to the ADL Manager promptly.
- Prepare study protocols for analytical method development, method validation, method transfer, forced degradation, and stability studies as per regulatory requirements and client specifications.
- Handle Teleconferences (T-Cons) with clients in coordination with the ADL Manager and HOD; document discussion points, action items, and commitments arising from each T-Con and circulate Minutes of Meeting (MoM) to all stakeholders.
- Draft and send written replies to client technical queries after thorough discussion and alignment with the ADL Manager and HOD; ensure responses are scientifically accurate, professionally worded, and submitted within agreed timelines.
B. Additional Responsibilities
- Monitor and observe ongoing analytical activities within the ADL team; compile daily/weekly progress updates and present findings to the ADL Manager for review and decision-making.
- Liaise with the Formulation Development department to gather inputs required for analytical documentation; ensure analytical timelines are aligned with formulation project milestones.
- Coordinate with the Regulatory Affairs team for preparation and compilation of analytical sections of CTD/ANDA/NDA dossiers including Module 3 documentation.
- Maintain a structured and up-to-date document control system for all ADL documents including version history, review dates, and approval status as per QMS requirements.
- Prepare and revise SOPs, formats, templates, and other QMS controlled documents specific to ADL activities; ensure documents are reviewed and approved within defined timelines.
- Maintain a project tracker / log for all active and upcoming studies; update status regularly and escalate delays or resource constraints to the ADL Manager.
- Assist in the preparation of responses to regulatory observations and queries related to analytical development received during USFDA, EU GMP, WHO, or CDSCO inspections.
- Coordinate instrument qualification documentation (IQ, OQ, PQ protocols and reports) and ensure records are maintained as per regulatory expectations.
- Support the ADL Manager and HOD in preparation of presentations, technical summaries, and internal review reports for management meetings.
- Guide and support junior documentation staff or trainees within the ADL team on documentation practices, data integrity (ALCOA+), and regulatory writing standards.
Qualifications & Education
- M.Pharm from a recognized university; specialization in Pharmaceutics, Pharmaceutical Analysis, or Quality Assurance preferred.
- 3 to 4 years of experience in an Analytical Development Lab within a pharmaceutical manufacturing or CRO environment, with demonstrated focus on documentation and client communication.
- Prior experience in handling client T-Cons, preparing regulatory dossier documents, and coordinating with formulation or regulatory affairs teams will be a strong advantage.
Skills & Competencies
Documentation & Regulatory Skills:
- Strong command over regulatory writing and technical documentation as per ICH, USFDA, EU GMP, WHO, and CDSCO guidelines.
- Hands-on experience in preparing AMV reports, method transfer protocols, stability protocols, SOPs, and CTD/ANDA dossier documents.
- Sound understanding of GMP, GLP, 21 CFR Part 11, and ALCOA+ data integrity principles.
- Proficiency in MS Office (Word, Excel, PowerPoint) for documentation, tracking, and reporting purposes.
- Familiarity with document management systems and version control procedures.
Communication & Coordination Skills:
- Excellent written and verbal communication skills in English for effective client and cross-functional interactions.
- Ability to handle client T-Cons professionally; skilled at drafting clear, concise, and technically sound replies to client queries.
- Strong coordination and interpersonal skills to manage communication between ADL, Formulation Development, QA, and Regulatory Affairs teams.
Soft Skills:
- High attention to detail with strong organizational and time management abilities.
- Ability to manage multiple documentation assignments simultaneously and deliver within deadlines.
- Proactive in identifying gaps in documentation or timelines and escalating appropriately.
- Willingness to take ownership of tasks and work independently with minimal supervision.
- Team-oriented with the ability to guide and mentor junior team members.
How to Apply
Interested candidates may send their updated resume mentioning "Application – ADL Scientist" in the subject line.
Email: [email protected]/[email protected]
Education:
Experience:
- Pharmaceutical : 2 years (Required)
Work Location: In person
