Head of MSAT

6 days ago

bangalore, 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.

  • Head of MSAT

    6 days ago

    bangalore, 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...

  • Head of Account Management

    1 week ago

    bangalore, India Curefit - house of cult Full time

    Curefit Healthcare Pvt Ltd is India’s largest fitness company. Founded in 2016 by Mukesh Bansal and Ankit Nagori, Curefit offers a comprehensive range of fitness services and products through its two brands, cult.fit and cult.sport. With a mission to make fitness fun, easy and accessible, cult.fit offers group workouts, online classes, sports facilities,...

  • Head of Transformation

    1 week ago

    bangalore, India Client of Mancer Full time

    Responsibilities Manage and lead the Transformation Program across the business-aligned teams Act as delegated owner on behalf of the line of business to manage the existing BOW and identify more opportunities & create new projects Help business teams articulate their transformation business problems lead complex cross-enterprise projects resulting in...

  • Head of Account Management

    1 week ago

    Bangalore Metropolitan Area, India Curefit - house of cult Full time

    Curefit Healthcare Pvt Ltd is India’s largest fitness company. Founded in 2016 by Mukesh Bansal and Ankit Nagori, Curefit offers a comprehensive range of fitness services and products through its two brands, cult.fit and cult.sport. With a mission to make fitness fun, easy and accessible, cult.fit offers group workouts, online classes, sports facilities,...

  • Virtual Chief Financial Officer

    1 week ago

    bangalore, India Client of Career Crafterz Full time

    This is a consultant role for an estimated period of 12-18 months.Time commitment required will be for 3-4 days in a week and will be hybrid mode (mix of virtual and work from office). Interested candidates can direct message me over linked in.Candidate Experience Criteria:- Should have worked for an Intellectual Property (IP) led organization.- Preferred...

  • Virtual Chief Financial Officer

    1 week ago

    bangalore, India Client of Career Crafterz Full time

    This is a consultant role for an estimated period of 12-18 months. Time commitment required will be for 3-4 days in a week and will be hybrid mode (mix of virtual and work from office). Interested candidates can direct message me over linked in. Candidate Experience Criteria: - Should have worked for an Intellectual Property (IP) led organization. -...

  • Head of Transformation

    1 week ago

    Bangalore Metropolitan Area, India Client of Mancer Full time

    ResponsibilitiesManage and lead the Transformation Program across the business-aligned teamsAct as delegated owner on behalf of the line of business to manage the existing BOW and identify more opportunities & create new projectsHelp business teams articulate their transformation business problemslead complex cross-enterprise projects resulting in...

  • Principal

    6 days ago

    bangalore, India VIBGYOR Group of Schools Full time

    RoleTo lead the school operations in line with the vision and mission of the organization, thus ensuring high levels of parent satisfaction and financial prudence on sustainable basisKey Result AreasBuilding an institution, which fosters and excels in Holistic Child Development and Performance. (20%)Projecting and planning infrastructure, fixed assets,...

  • Principal

    1 week ago

    bangalore, India VIBGYOR Group of Schools Full time

    Role To lead the school operations in line with the vision and mission of the organization, thus ensuring high levels of parent satisfaction and financial prudence on sustainable basis Key Result Areas Building an institution, which fosters and excels in Holistic Child Development and Performance. (20%) Projecting and planning infrastructure, fixed...

  • Chief Financial Officer

    3 weeks ago

    bangalore, India Client of IFCCI Full time

    IFCCI HR & Recruitment Services Team has been retained by a Large French Services group (a global player) to manage the search for the Chief Financial Officer of their Indian Subsidiary to support the development of the Group’s activity in India. The post The Chief Financial Officer reports hierarchically to the CEO of the subsidiary in India and...

  • Sales Manager

    4 weeks ago

    bangalore, India Client of Vistas HR - a leading Frozen Food Company in India Full time

    Greetings from Vistas HR !Hiring for Sales Manager ( Frozen Food ) for a leading Frozen Food company, Head Quarter : BanglorePosition title : Sales Manager ( Frozen Food )Head Quarter : BangloreEducational Qualification : Graduate / Post-GraduateExperience : Minimum 10 years of sales experience of which 5+ years in frozen food industryCTC : Open, based on...

  • Internal Auditor

    1 week ago

    bangalore, India East Point College of Medical Science & Research Centre Full time

    MAJOR RESPONSIBILITIES A. Review and Evaluate Operating Areas of East Point Group of Institutions and Related Enterprise Partners 1. Perform operational and financial audit assignments and other audit services identified by the Head of Internal Audit. 2. Identify areas/activities requiring audit review through observations made during the course of...

  • Head of Business Development

    3 weeks ago

    bangalore, India Client of Maxima Global Executive Search Full time

    Our Client is a leading player in the real estate and Infrastructure sector with an impeccable track record of developing world class commercial projects and technology parks. They have ambitious growth plans and they have embarked on developing their lanbank into best known destinations for global corporations to set up their operations in their properties....

  • Sales Manager

    4 weeks ago

    Bangalore City, India Client of Vistas HR - a leading Frozen Food Company in India Full time

    Greetings from Vistas HR ! Hiring for Sales Manager ( Frozen Food ) for a leading Frozen Food company, Head Quarter : Banglore Position title : Sales Manager ( Frozen Food ) Head Quarter : Banglore Educational Qualification : Graduate / Post-Graduate Experience : Minimum 10 years of sales experience of which 5+ years in frozen food industry CTC : Open, based...

  • Field Manager

    4 weeks ago

    bangalore, India Otis College of Art and Design Full time

    Date Posted: 2024-02-13 Country: India Location: No: 27, MK Towers, Langford Raod, Shanthi Nagar, Bangalore - 560 027., India Designation : Field Manager – Service Location – Bangalore Department - IND Service Overall responsible for service revenues from area. Provide leadership Supervisor and various stake holders in the ...

  • ASM - Contract Engineering - Mechanical

    2 weeks ago

    bangalore, India Otis College of Art and Design Full time

    Date Posted: 2024-05-19 Country: India Location: No.92 Jigani Industrial Area II, Jigani Village, Aneka,Karnataka, BANGALORE -560 105, India JOB RESPONSIBILITIES Abide by Ethics, Internal Controls, and safety policies as per company standards. Support deployment of new products and components. Preparation of Bill of Material (BOM) and...