Deputy Manager/ Manager, Analytical method transfer

Expected qualification:

• Minimum M. Tech/M.SC with Biotechnology, Biology, Biochemistry, chemical

Engineering, or related field.

• Minimum 10-13+ years hands on experience for M. Tech/M.SC level candidates

(minimum 12+ years’ experience for B.S. candidates) in biotechnology/pharmaceutical

manufacturing practices, guidelines, management practices, cGMP knowledge, and

production and planning operations.

• Experience in method development and its qualification, validation studies for analytical

assays such as HPLC, GC, SDS-PAGE, Agarose gel electrophoresis, Densitometry, dd-

PCR and RT-PCR, ELISA, UV-Visible spectrophotometry, and Western-Blot etc. and

microbiological techniques such as BET - rapid release methods (Bac-T, PTS, MCS) and

gel-clot, Bioburden and Sterility testing (Conventional and rapid tests).

• Should have a complete awareness of analytical method qualification and validation as per

regulatory requirements.

• Should have a complete understanding of method qualification criteria, Handling of

reference standards and reagents, routine calibration, and maintenance of laboratory

instruments.

• New facilities and equipment commissioning, and qualification experience are added

advantages.

• Should be familiar with regulatory approvals of products at different stages and exposure

of audits to regulated and emerging markets are compulsory.

• Candidate should have proven track records of method validation with accuracy and

highest standards of repeatability as per defined specifications.

• Candidate should be familiar with analyst qualification.

• Should have a complete understanding of cGMP, GLP, GDP (Good documentation

practices) and data reliability.

• Technical proficiency required for successful validation and method transfer of analytical

assays.

• Working knowledge of clone development, upstream fermentation, and downstream

purification techniques.

• Relevant industry experience in GMP environment.

• Must be self-motivating, organized, and proactive.

• Strong knowledge of Environmental Monitoring (EM) requirements and tests (viable and

non-viable), aseptic process validation, identifying microbial contaminants, and other

applicable methods for the testing of biopharmaceuticals.

• Must have training and experience to work safely around laboratory equipment,

biohazardous substances (BSL-2/BSL-3), and/or hazardous chemicals in manner that

complies with safety and quality standards.

• Working knowledge of quality systems and regulatory requirements (21 CRF Part

11/210/211/1271, ISO 14644-1, USP, EP).

• Strong technical aptitude including demonstrated experience in applying scientific

reasoning to solve complex problems.

• Well versed with software such as Lonza MODA, LIMS, track wise, Documentum for

microbiology functions.

• Strong knowledge of computer systems including base of computer systems including base

of MS word, MS excel, MS PowerPoint, and MS projects in addition to familiarity with

statistical software and planning with inventory systems.

• Ability to work hours necessary to support production and/ or product transfer activities.