Senior Vice President – Chemical Drug synthesis R&D

Job Description

We are Hiring!!! (Senior level) Position: Senior Vice President – Chemical Drug synthesis R&D- Active pharmaceutical ingredients (APIs) across generic small molecules, complex peptides, and oncology therapeutics for global regulated markets (USFDA, EMA, PMDA, CDSCO, NMPA) (1 vacancy) Department: Synthesis R&D, Executive Scientific Leadership and R& D Strategy, Specialized Technical & Portfolio Responsibilities, Scale-Up, Technology Transfer & Commercialization, Global Regulatory Compliance & Quality, Talent Development, Operations & Strategic Alliances Experience: 18 years and more Location: Pashamylaram IDA, Hyderabad, India Qualifications: M.Sc/M.Pharm/M.tech/Ph.D (Chemistry) Send your profile to: sreddy@bachwellpharma.com (main ID), bachwellpharma@gmail.com, hr@bachwellpharma.com Core Job Responsibilities 1. Executive Scientific Leadership and R&D Strategy Portfolio Strategy: Lead the long-term Ramp;D roadmap for generic drug APIs, synthetic/semi-synthetic peptides, and high-potency oncology therapeutics (including cytotoxic APIS and antibody-drug conjugate (ADC) payloads). Innovations & IP Generation: Capital & Budget Management: 2. Specialized Technical & Portfolio Responsibilities A. Synthetic amp; Solid-Phase Peptides Direct process chemistry for short, long, modified, and cyclic peptides utilizing Solid-Phase Peptide Synthesis (SPPS), Liquid-Phase Peptide Synthesis (LPPS), and hybrid/chemo-enzymatic approaches.Oversee critical purification, cleavage, isolation, and lyophilization techniques (prep-HPLC, ultrafiltration) while minimizing side reactions (racemization, deletion sequences, aggregation). B. Oncology amp; High-Potency APIs (HPAPIs) Oversee high-potency process development operating under high containment levels for targeted cancer therapies, cytotoxic agents, and payload-linkers for ADCs. Enforce rigorous containment validation, occupational health hazards management, and specialized EHS protocols for high-potency chemical synthesis labs and pilot plants. C. General Generics amp; Complex Small Molecules 3. Scale-Up, Technology Transfer & Commercialization Pilot amp; Plant Scale-Up: Oversee tech transfer from lab-scale bench chemistry through pilot plants to commercial cGMP API manufacturing sites. Process Optimization: Impurity & Nitrosamine Profiling: 4. Global Regulatory Compliance & Quality Regulatory Dossier Filing: Partner with Regulatory Affairs to author, review, and defend global Drug Master Files (DMFs), ASMFs, and CEP applications across FDA, EMA, PMDA, and other health authorities. cGMP & Data Integrity: 5. Talent Development, Operations & Strategic Alliances Organizational Leadership: Lead and scale a multi-disciplinary team of Vice Presidents, Directors, Principal Scientists, and Process Chemists across route scouting, analytical development, and pilot operations. External Collaborations & CRO/CDMO Management: