דרושים ב-Msd ב-India, Mumbai

Job Description

Primary responsibilities for this position include, but are not limited to, the following:

• Lead and act as the primary interface on technical issues between technical operations and the external partner.

• Provide technical leadership within the technical operations group for the commercialization and manufacture of drug substance.

• Provides technical guidance to the external partner, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.

• Collaborates with external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) performance, fostering pro-active risk management mindset and continuous improvement

• Executes technical due diligence assessments at external partner(s).

• Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.

• Executes validation strategies for new and existing products.

• Provides manufacturing process support to external partner(s) to resolve production issues and to provide guidance on process and capacity optimization.

• Supports/coordinates/manages complex investigations, with appropriate interface with other impacted manufacturing sites.

• Provides a technical review of external partner process change requests, deviations, and master batch record changes. Minimizes duplication of efforts between external partner and our systems.

• Drives and supports continuous process verification and process performance monitoring program for all products under his/her responsibility.

• Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements.

Education and Minimum Requirements:

• Bachelor’s degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer

Required Skills and Experience:

• Minimum of 5 of experience in drug substance with experience in leading Drug Substance new product introduction, technical transfers, commercial manufacturing
• Demonstrated knowledge and experience in process development, scale up and process robustness, including shop floor (person in plant) support.
• Strong problem-solving skills, root cause analysis and risk assessment/mitigation
• Ability to work effectively across boundaries to build strong collaborative relation with internal and external teams, to drive alignment and results
• A high level of effectiveness in professional and interpersonal communication skills, including stakeholder management, are required.
• Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture.
• Must be able to work under own initiative, prioritise appropriately based on business need and work within tight deadlines.
• Flexibility and the ability to work independently as well as excellent organizational skills.
• Strong knowledge of quality systems, drug substance manufacturing and validation.
• Excellent command of English (both written and oral).
• Travel will be a requirement of this position at approximately 25%

Preferred Experience and Skills:

• Knowledge and experience of flow chemistry, enzyme manufacture and bio-catalysis are desirable but not essential.
• Lean Manufacturing / Six Sigma Experience
• Project management experience
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

• Research and communicate with the business and cross functional colleagues on legal concepts and draft or review non-complex legal contracts (for e.g., non-disclosure agreements).
• Support in legal review of promotional materials according to local laws and our company policies and standards.
• Maintain oversight and ensure compliance of all corporate secretarial matters with support of third-party Corporate Secretarial firm.
• Co-ordinate with external counsels on legal advice and ensure timely receipt of deliverables and raising of invoices.
• Support and assist the Director, Legal and Compliance with the preparation of compliance presentations, internal trainings etc.
• Support the Director, Legal & Compliance in handling compliance-related matters and enquiries, in collaboration with local business practices officers and other business divisions within our company
• Monitor changes and developments in the legal and regulatory environment in which our company operates and provide updates within the Legal and Compliance team.• Support the global intellectual property group in coordinating the local trademark and patent filings and collect and disseminate intellectual property information for local management, as appropriate.
• Assist the Director, Legal & Compliance in conducting internal investigations, where necessary, in collaboration with Global Security, Global Investigations and Office of Ethics, analysis and advisory activities.
• Understands and proactively identifies privacy risks and gaps in the local business/function

Standards applicable to the role – capable to adhere to and exhibit the following qualities:

• Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions, comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
• Foster Collaboration - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of our company.
• Speak openly, honestly and with conviction.
• Focus on Customers & Patients - Focus on delivering value for customers, including patients, by understanding and meeting their needs in an ethical, responsible and sustainable way.

• Bachelor’s or higher degree in law from accredited law school and admitted to practice law in India.
• Qualified as a company secretary.
• 3 years or more of post-admission experience.
• Additional professional or academic legal qualification would be advantageous

• Strong research, drafting, interpersonal and communications skills
• Relevant knowledge of legal principles and sound legal advisory skills
• Ability to manage corporate secretarial work independently.
• Technologically savvy, intermediate to advanced proficiency in MS Microsoft Office Suite (Outlook, Word, Excel). Ability to use technology as an enabler for efficiency and effectiveness
• Ability to communicate and work collaboratively and effectively with cross functional teams and good attention for details.
• Ability to work well under pressure - manage workflow, competing priorities and changing circumstances.

• Prior in-house legal and compliance experience with a multi-national pharmaceutical company preferred.
• Familiarity with the UCPMP and local pharmaceutical related laws and regulations in India would be highly advantageous

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.