Panacea Biotec is one of India's leading research based health Management Company with well demonstrated R&D, manufacturing and sales & marketing capabilities. Panacea Biotec is 2nd largest vaccine producer, 3rd largest Biotechnology Company and amongst the top 50 pharmaceutical companies in India.
We are looking for professionals in the following areas for our R&D Operations based at Lalruf Punjab) and Mumbai.
Post: DGM/GM-RA, Manager/Team Leader, Assistant Manager/ Manager, GM/Sr.GM
REGULATORY AFFAIRS (ROW)
Designation: DGM/GM-RA (For ROW Markets)
Post Code: RA
Location: Mumbai
Qualification & Experience: Ph.D / M.Pharma - Pharmaceutics with 15 to 18 years of relevant experience in regulatory affairs for ROW with in-depth understanding of regulatory nuances of Russia, Brazil, S Africa etc. Candidate with R&D background would be given preference.
Profile:
• To play an integral role in the process of developing, manufacturing, registering and introducing safe and effective Pharmaceuticals & Bio-similars products worldwide, with strategic planning, pre and post approval responsibilities, internal and external interfacing and communication as key responsibilities.
• Compilation of initial dossiers and query responses as per regional/national competent agency requirements in the formats such as Paper CTD, ACTD, Nees and or eCTD for Solid Orals and Parenterals.
• Managing the product life cycles from initial submission, query resolution, approval of submitted drug product and related re-registration activity. Submission of variations as per regional requirements.
• Finalization of action items, negotiating user friendly timelines for receipt of documents from stakeholders and liasoning with Regional FDA office, DCGI and CDSCO.
FRD- ORAL DRUG DELIVERY
Designation: Manager/Team Leader-Oral Drug Delivery (FRD)
Post Code: ODD
Location: Mumbai &Lalru(Punjab)
Qualification & Experience: Ph.D./ Post-Doctorate in Pharmaceutics/ Pharmaceutical technology, M. Pharm (Pharmaceutics) GATE / GPAT qualified about 5-6 years of experience in R&D in the area of novel oral delivery systems.
Profile:
• Handling of independent research projects and patent search activities related to projects based on novel oral drug delivery science.
• To manufacture batches for pilot Bio-study at pilot plant at R&D, interpretation of BE study results. Designing strategies for non- RLD strengths to qualify for bio-waiver.
• Preparation of master formula card, finalization of product specifications, stability schedule, product development report (PDR) as per Quality by Design approach.
• Technology transfer of developed MR/IR products and support to Technology Transfer team for smooth execution of scale-up and exhibit batches for regulated markets.
ANALYTICAL RESEARCH & DEVELOPMENT
Designation: Assistant Mgr/ Mgr.- ARD
Postcode: ARD
Location: Lalru (Punjab)
Qualification & Experience: M.Sc.-(Chemistry), M.Pharm. (Pharmaceutical Chemistry) with 6-8 year of experience
Profile:
• Knowledge of Analytical method development of Assay, RS, Impurity Characterization, Dissolution and residual solvent of low dosages formulation product as per USFDA Guideline.
• Knowledge of cGMP/cGLP and Qbd rules & guidelines, knowledge of UV, IR HPLC-UV (PDA, ELSD, ECD, Rl), GC-FID (NPD, TCD), DSC, AAS, NMR, pXRD, potentiometer, paragraph, particle size analyzer, GC-MS/MS, LC-MS/MS.
PHARMA RESEARCH (R&D)
Designation: GM/Sr.GM(R&D)
Postcode: R&D
Location: Mumbai
Qualification & Experience: Doctorate in Pharmaceutics from Premier Institute with 10-12 years in Pharmaceuticals Product Development (NDDS/generics). Candidates having exposure to Parenterals, Oncology products, Oral CR products and experience on technologies like Lyophilization, Liposomes, Nanoparticles, Microspheres, Depot Injections, etc. shall be preferred. Candidate should be open for relocation should the need arise in future.
Profile:
• Lead a team of formulation and analytical scientists to Design, Develop and plan scientific experiments for dosage forms i.e. Patenting strategies, Pre- formulation study, Prototype development lab & stability batch, Scale-up & Pre Exhibit Batch at the shop floor as per the Regulatory Guidelines.
• Participate in screening and selection of new opportunities for development attheR&Dand propose strategyand budgetforthe same.
• To develop the product for the ICH region with good experience of working on platform technologies in the oral drug delivery and injectable dosage forms for the value added generics and generics business portfolio.
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FRD- PARENTERAL RESEARCH
Designation: Manager/Team Leader-Parenteral Research (FRD)
Postcode: PR
Location: Mumbai
Qualification & Experience: PhD (Pharmaceutics) with 5-8 Years of experience with specific exposure to injectables in Onco Field only.
Profile:
• Responsibility for end to end product development for the desired market within the specific timelines with minimum deficiencies.
• Expertise in Parenterals on Nano Technology, Microparticles, Lyophilization or liposomal technology based products.
• Ensure the timely & accurate provision of the data to the regulatory division for minimal queries.
• Scale up from R&D Scale to Pilot Scale,TechnologyTransfer.
• Complete concept, layout, qualification and validation details for containment facility for products at R&D and Production.
• Develop non-infringement routes for product development.
MANAGER- PROJECT MANAGEMENT
Designation: Project Management- Generics&NDDS
Post Code: PM
Location: Mumbai
Qualification & Experience: M. Pharm/ Ph.D. with an MBA (Pharmacy) degree is desirable alongiwith 10 years of experience.
Profile:
• Determine the optimal mix and sequencing of proposed projects to best achieve the organization's overall goals and ensures the continuous flow of projects from concept to launch of product in market and track each project in terms of direction, time&cost.
• Overall R&D portfolio alignment with business needs and strategy
Eligible candidates can appear for Walk-in-Interviews at venue of their choice between 1000 hrs - 1500 hrs.
(With prior appointment through email to save time and avoid waiting) to be held on
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Date |
Venue |
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26th December, 2014 |
Panacea Biotec Ltd, 7th Floor, SagarTech Plaza,"A"Wing, Saki Naka, Andheri (East), Mumbai - 72 |
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27th December, 2014 |
Hotel Suba Star, Judges Bungalow Road, Bodakdev, Opp. Premchand Nagar, Near AakashTower, Ahmedabad, Gujarat - 54 |
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28th December, 2014 |
Sarovar Portico Hotel, Aditya Park-A, Aditya Trade Centre, Ameerpet, Hyderabad - 38 |
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Interested candidates who meet the above job criteria can also send their application at careers@panaceabiotec.com mentioning the position code in the subject line within 7 days of publishing of this advertisement.
Last Date: 29th Dec, 2014
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