Pharmanovia Hiring for Associate Technical Manager at Vadodara, Gujarat, India Full Time

Job Description

Associate Technical Manager – FormulationsMumbai or Vadodara, IndiaSalary: Competitive + Benefits + BonusIf you are an experienced Pharmaceutical Formulation Professional in Drug Product Development and Manufacturing under a regulated environment with a focus on Sterile/Parental delivery systems based in Mumbai / Vadodara, India then we want to hear from you! We are looking for extensive experience in the following areas:

• Clear Liquids
• Low & High Viscosity Suspension
• Oncology Formulation
• Liquid and Lyophilized Formulations

Join us and help us achieve our goal to be an agile and imaginative global specialty pharma business. Be part of improving people’s lives every day by instigating a paradigm shift in revitalising iconic medicines and accessing the latest technology to make healthcare better for everyone!Why PharmanoviaPharmanovia is a fast-growing pharmaceutical company with a portfolio of over 20 brands across 140+ markets. Our team of over 250 employees are based globally across our offices in the UK, Denmark, Netherlands, Switzerland, Dubai, India, Australia, Singapore and Italy.Since we first opened our doors in 2013, we have focused single-mindedly on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the globe. We specialise in many different areas including cardiovascular, endocrinology, neurology, and oncology.About the role: As the Associate Technical Manager – Formulations you will be instrumental in managing activities associated with Technology Transfer (T/T) related to Manufacturing of Drug Products from their current Contract Manufacturing Site (CMO) to the alternative CMOs.You will provide technical advice and support on issues related to the manufacturing process of existing and potential products. Further, you will be responsible for:

• Project Management and co-ordination with current Contract Manufacturing Site / Contract Testing Laboratory for generation of various Technology Transfer documentations
• Develop Project Plans, in conjunction with other relevant parties, in relation to product site transfers or new product development projects, to include timescales, costs and identifiable risks
• Review and approval of Technology Transfer documentation
• Direct/Indirect supervising of Technology Transfer activity
• Troubleshooting and corrective & preventative actions implementation during Technology Transfer wherever required
• Providing information to internal stakeholders e.g., Regulatory Affairs for filing necessary variations & QA for site quality documents
• Manage and implement agreed project plans in accordance with the product licences and Good Manufacturing Practice guidelines
• Report issues / deviations from plan, costs, strategies timings and progress
• Generate, negotiate and see through to approval the Quality and Technical Agreements between Pharmanovia and its partner Contract Manufacturing Organisation
• Generation, review and technical approval of technical documentation including but not restricted to Protocols, Manufacturing and Packaging Batch Manufacturing Records, Validation Reports, Specifications, Tooling Drawings
• Ensure compliance in Technology Transfer and Process Changes with EU GMP and other market requirements
• Resolve Technical and Quality issues including unforeseen deviations relating to the production and testing of products by Contract Manufacturers and Testing Laboratories. Report issues to the QP who is responsible for releasing these products to the market
• Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products
• Work with Regulatory, as part of a multidisciplinary team, regarding new and existing licence applications or variations
• Assist in sourcing alternative active pharmaceutical ingredients suppliers, Drug Product, Primary and Secondary manufacturers
• Assist when required, in technical Due Diligence and support in relation to the acquisition of new products, licences and / or dossiers

About you:

• Master of Pharmaceutical Sciences
• At least 5 – 10 years’ hands-on experience in development, manufacturing & packaging of oral solid dosage form experience
• Pharmaceutical Drug Product Development Sterile / Parenteral
• Pharmaceutical Drug Product Validation & Technology Transfer Sterile / Parenteral
• Primary & Secondary Packaging of Drug Products
• Pharmaceutical Project Management
• Drug Product Development and Product Manufacturing- Other Dosage Forms such as OSD
• Drug Substance & Drug Product Analysis
• Analytical Method Development & Validation
• Exposure in handling formulations classified as Microemulsions, Nanoparticles etc. of advantage

What we offer: We offer a competitive salary and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.Job Types: Full-time, Regular / PermanentApplication Question(s):

• Would you wish to work in Mumbai or Vadodara?

Education:

• Master’s (Required)

Experience:

• Oral Solid Dosage Form: 1 year (Preferred)
• development and scale up of parenteral dosage forms: 1 year (Preferred)
• handling parenteral suspension: 1 year (Preferred)