Responsible for Smooth Functioning of plant & to meet monthly production with optimum utilization of resources of Plant & also responsible for research & development of Immunology - Rapid + Biochemistry + Hematology + Mol Diagnostics and lateral flow test to ensure the addition of new products to fill the gap in portfolio for the business growth and team management. The incumbent will be responsible for adding new products as well as improvement of existing one as per requirement & Plans, Coordinates and Execute Manufacturing activities designed to ensure continuous production of products consistent with established standards by performing the following duties and responsibilities.
What we're looking for:
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Post Graduate in Biotechnology / BTech Biotech. / PhD in Biotechnology or Microbiology and MBA in Operations Management would be Preferred
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Minimum 10 -12 Yrs Experience in Invitro Diagnostics field would be must with Minimum 5 Yrs of People Handling Experience.
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Expertise in developing in vitro Diagnostic kits such as ELISA, rapid card test, Biochemistry , protein expression and purification
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Scientific & Technical knowledge in diagnostic/life science business for research and development of diagnostic products.
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Designing & Prototyping various diagnostic products by gaining an advantage over competitors in the market.
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Sound knowledge of ELISA, Clinical chemistry, Rapid techniques and Hematology
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Skilled in resource allocation to meet tactical demands and strategic business needs.
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Customer (internal and external) driven approach.
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Knowledge of investigations tools.
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Demonstrated knowledge and application of ISO 9001 & ISO 13485, Computer skills in MS Office, MS Project etc.).
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Ability to technically review documents from other areas for departmental impact.
How you'll thrive and create an impact:
Plant Operations:-
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Responsible for Plant P&L and Budgeting
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Provide inputs towards formulation of Plant strategy and create a strategic roadmap for Dehradun plant to deliver organization expectations.
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Manage relationship with regulatory bodies and internal customers to build a favorable image of Avantor Performance Materials India Limited.
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Ensure technical development of plant resources, systems and processes to drive long term sustainable quality as well as efficiency within plant team.
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Ensure Plant Quality compliance with organizational processes as well as regulatory and statuary requirements.
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Develop a high performance work environment to build a capable and motivated team within Dehradun Plant.
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Ensure Plant EHS Operations in compliance with Global guidelines
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Driving ABS Culture in the Plant as to improve the Processes
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Responsible for Plant Procurement and Inventory Controls.
R & D:-
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R&D team management and project assignment: Planning management of projects, maintaining timelines and establishing close connection with team and regular updates with all internal (Production & Quality) and external stakeholders (Regulatory, Business and Marketing).
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Handling lifecycle of projects: Designing new R&D project and its execution plan (Development, Evaluation and Technology transfer); Improvement plan as per market input and its execution.
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Project alignment as per business requirement: Market requirement analysis upon discussion with sales and marketing team to prepare inputs for R&D and feasibility mapping.
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Project costing and R&D budget planning
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Maintenance of company’s Intellectual property (IP)
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Training: Safety; Scientific/Technical; Regulatory and compliance etc.
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Handling the R&D projects for their design & development, technical trouble shooting, documentation, cost analysis of new products and their quality standard.
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Vendor identification, finalization, negotiation, and sourcing of key RM/PM/equipment to be used for new product development.
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Reviewing the potential of upcoming projects/technologies/ products in terms of market potency, competency, costing, timeline and their scope.
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Preparation and documentation as per ISO 13485 and ensuring the compliance
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Maintain the R&D data and technology oriented methodologies as per the company policies. Keep recording the raw R&D data in proper manner.
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Technical and scientific support to R&D, production, PMT team for related projects and activities.
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Monitoring of in-house developed products from market and update on technological advancement.
Additional QMS
- Review and Approval of Department Procedures and Protocols.
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Necessary change controls are initiated & adequately approved before change in any product/
- process/design etc.
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Timely completion of investigations & action points for Incidents/CAPA and audit observations.
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Ensure Adherence/Compliance to records management policies and procedures as applicable.
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Conduct the training timely as and when required.
Others:
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Maintain 5S in work area.
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Ensure safety requirements are in place all the time.
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Ensure Current Good Manufacturing & Good Documentation practices are followed all the time.
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Timely intimation of NC for Investigation and Non-conformance (NC) closure.
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In depth knowledge of tools for investigation of NC.
AUTHORITIES (if applicable)
R & D
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Authorize to Approve procedures and protocols.
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To verify the Log books of R&D.
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Authorize to conduct trainings.
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Authorized to approve initiation of BMR/BPR issuance request.
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Authorized for final review and approval of Completed BMR/BPR.
Other Skills
- Time management
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Team Leader
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Computer skills
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Problem-solving skills
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Administrative skills
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Effective written, verbal and listening communication skills.
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Must be honest and trustworthy.
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Must be respectful and flexible.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
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