Pharmaceutical Technical Process Specialist

4 days ago

Hyderabad Secunderabad Telangana Nizamabad Warangal, India beBeeTechnical Full time ₹ 8,00,000 - ₹ 12,00,000
Job Title:
Tech Product Specialist

About the Role:
As a key member of our manufacturing team, you will be responsible for ensuring the smooth production and commercialization of products. Your technical expertise will play a crucial role in maintaining product quality and process robustness at our sites. You will work closely with internal stakeholders and external suppliers to drive operational excellence and implement science-based approaches to ensure sustainable product quality.

Your Key Responsibilities:
  • Provide technical support to internal manufacturing sites and external suppliers to improve product process capability and maintain knowledge up-to-date.
  • Implement science- and risk-based approaches to ensure product quality can be sustainably reproduced.
  • Maintain the availability of all relevant technical documentation, such as protocols, reports, risk assessments, and concept papers.

Product Stewardship:
You will act as a technical expert to maintain oversight and knowledge of entire manufacturing processes throughout the commercial lifecycle at our sites. This includes ensuring a proper understanding of manufacturing processes and influencing factors, analyzing product-specific manufacturing data, and assessing the impact of technical changes on product quality and process robustness.

Validation Support:
You will be responsible for validation oversight and maintenance of product validation status. This includes challenging defined control strategies, reviewing quality risk analyses, and ensuring that technical batches generate sufficient process knowledge by thoroughly testing critical variables and using output to verify critical process parameters.

Launch & Transfer Support:
You will participate in external supplier/product evaluation and selection processes, gather technical information on manufacturing process capability, and provide necessary data for technical activities involved in tech transfer of products. You will also define product acceptance criteria for transfers and monitor routine manufacturing performance following transfer.

Interface to Development:
You will ensure new products and processes are well-developed for commercial scale and entire product lifecycle at our sites. This includes providing input to formal stage gates during development and supporting development of comprehensive control strategies to meet manufacturing requirements.

Manufacturing & Operational Excellence:
You will define and execute design and control optimization projects where needed, providing SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.

Training:
You will own the training curriculum for your job description and direct reports.

Requirements:
  • Bachelor's/Master's degree in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
  • Minimum 8 years of experience in pharmaceutical (chemical) manufacturing.
  • Experience in a global/matrix environment in the pharmaceutical industry.
  • Comprehensive knowledge in pharmaceutical (chemical) technology.
  • Project management experience.
  • Drug development experience.
  • Sound experience of data handling and applied statistics.

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