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Head of MSAT

3 months ago

Bengaluru, India tCognition Full time

Job responsibilities:

• Lead projects for Process Transfer at various scales and required grades (R&D, GLP, GMP

etc.) to the manufacturing facility.

• Work with cross-functional teams across the organization to develop and implement

project management processes and tools to track and control projects.

• Work closely with Process and Analytical Development team leads to provide technical

inputs, review documents, and ensure that the processes are followed to plan, monitor, and

control the progress of the work streams.

• Propose a list of activities and Project Key Milestones (on the critical path) in line with the

project plan and seek cross-functional alignment.

• Provide updates on the progress of various projects to the leadership of Tech Ops and

management, as required through periodic reports and presentations.

• Drive the technical operations team in monitoring & identifying risks, perform quantitative

& qualitative risk analysis, define & implement mitigation plans.

• Furnish technical assistance to the development teams in co-ordination with the

product/process expert.

• Plan resource management, estimate activity resources, acquire resources, develop teams

& control resources.

• Lead to transfer and validate all production processes and control subsequent actions until

routine application.

• Assessing, finalizing, supporting and tracking project budget.

• Identify and follow-up project quality requirements. Define and implement Quality

measurements to control Quality.

• Coordination within the Technical Operations department and/ or representing the

department for activities related to the greenfield project such as URS preparation,

qualification and validation activities etc.

• Help build and/ or manage manufacturing team initially for research grade material and

then eventually for cGMP grade (for first product).

• Additional responsibilities not listed may be assigned as needed by leadership.


Expected qualifications:

• Ph.D or M.S. in microbiology, biotechnology, biology, biochemistry or related field.

• 7-9 years of experience (PhD) or 12-14 years hands on experience in biopharma

manufacturing practices, guidelines, management practices, cGMP knowledge, production

and planning operations.

• Experience in microbial culture and fermentation-based manufacturing of products of

interest (experience with mammalian cell-based processes is a plus)

• Should have a complete awareness on upstream process scale up, scale down, kLA

determination, intermediate and process hold time determination, stability studies, mixing

studies and defining the fermentation parameters at pilot and GMP scale.

• Should have a complete awareness on downstream process scale up, scale down, DBCs

and SBCs determination of chromatography resins, Intermediate and process hold time

determination, Stability studies, mixing studies and defining the fermentation parameters

at pilot and GMP scale.

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

regulatory requirements.

• Should have a complete understanding of upstream and downstream equipment design,

critical process parameters and troubleshooting of process.

• 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 technology transfer with successful scale

up and highest success ratio to executed fermentation batches with desired quality

attributes.

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

advantages.

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

and data reliability.

• Technical proficiency required for aseptic microbial fermentation, step recoveries

improvement, quality improvements, stabilities studies, formulation development.

• Relevant industry experience in GMP environment.

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

• Strong technical aptitude including demonstrated experience in applying scientific

reasoning to solve complex problems.

• 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.