Career

Position: Manager - Formulation Development Lab (R&D Unit)

Location: Ahmedabad

Department: Research & Development (R&D)

Reports To: Head of R&D

Employment Type: Full-Time

About the Company: 

Molkem delivers innovative and market-driven products and solutions in the field of Pharmaceuticals, Dyes, Pigments, Food, Specialty, Fine Chemicals, and Cosmetics.

Molkem fosters a globally diverse team and serves 170+ clients across 40+ countries.

Molkem is establishing its state of art R&D Unit at Ahmedabad.     

Position Summary: 

The Manager of the Formulation Development Lab (FDL) in the R&D unit is responsible for leading the formulation development team in the design, development, and optimization of pharmaceutical formulations. This role includes overseeing lab operations, managing projects, ensuring compliance with customers, regulatory requirements, and driving innovation to create high-quality products.

Key Responsibilities:

• Lead, mentor, and develop a team of formulation scientists and technicians.
• Set objectives and performance goals for the team and conduct regular performance reviews.
• Oversee the formulation development projects from concept to commercialization.
• Develop project timelines, allocate resources, and ensure timely delivery of project milestones.
• Coordinate with cross-functional teams including Analytical Development, Quality Assurance, Regulatory Affairs, Purchase, Project management and Stores.
• Provide technical guidance and expertise in the development of various dosage forms (e.g., solid, liquid, semi-solid, injectable).
• Design and execute experiments for the development and optimization of formulations.
• Review and interpret experimental data to make informed decisions.
• Ensure all formulation development activities comply with relevant regulatory requirements (e.g., FDA, EMA, ICH).
• Prepare and review technical documents and reports for regulatory submissions.
• Stay updated with the latest regulatory guidelines and industry trends.
• Manage daily operations of the formulation development lab including equipment maintenance, procurement of materials, and safety protocols.
• Implement and maintain good laboratory practices (GLP) and standard operating procedures (SOPs).
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of formulation development processes.
• Stay abreast of the latest technological advancements and incorporate them into the lab`s operations.

Qualifications:

Education:

Ph.D. or Master’s degree in Pharmaceutics, or a related field.

Experience

• Minimum of 8-12 years of experience in pharmaceutical formulation development.
• At least 2-5 years in a Team handling role within an R&D environment.

Skills and Competencies

• Strong leadership and team management skills.
• In-depth knowledge of pharmaceutical formulation development processes and techniques.
• Excellent project management, and Project presentation skills.
• Proficiency in regulatory requirements and guidelines.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Proficient in relevant software and tools.

JD - Head-Finance & Accounts

• Determining financial objectives. Designing and implementing systems, policies, and procedures to facilitate internal financial control.
• To formulate KRAs/KPIs for yourself and your team at the beginning of the financial year and its monthly monitoring.
• Preparing Annual Budget and forecasting trends.
• Develop reports for top management summarizing the business`s financial position in areas of income, expenses, capital usage, and cash flows, and coordinate the preparation of strategic plans, budgets, and financial forecasts.
• Developing and updating accounting, finance, and management policies and procedures.
• Effective Cash Flow Management.
• Monitoring budgets and comparing them with actual costs and revenues related to purchase, marketing, and capital.
• Coordinating the preparation, maintenance, and filling of projected P&L Accounts, Bills Discounting, and Balance Sheets as required by bank authorities and other financial institutions.
• Coordinate the preparation of Financial Statements, Financial Reports for internal usage.
• Getting control accounts reconciled and sorting out the discrepancies.
• Liaison with business-related organizations such as Banks, RBI, ECGC, etc.., and preparing budgets, i.e., systemizing departmental work.
• Handling Reserve Bank of India queries for export/import matters and carrying out all correspondence with the bank.
• Filing GST returns, E-TDS payments & E-TDS quarterly returns, independent handling of GST, TDS & Income tax assessment.
• Furnish ROC and Company secretary compliance and Statutory Audit.
• Carry out and finish GST assessment and audits.
• Remitting foreign currency for import advance & other expenses like traveling, consultancy, advertising, and project export.
• Profitability and capex monitoring of Domestic as well as all foreign subsidiaries.
• Digitized various MIS reports that can be extracted from ERP systems and linked to POWER BI tools. Reports reflect real-time data which helps management decision-making at the contract review level.
• Finalization of books of accounts of overseas subsidiaries.
• Closely reviewing accounting of related party and inter-department transactions.
• Negotiating with the banks for export documentation requirements.
• Opening LC for inland and foreign parties, bank guarantee for the import & PCB for the purchase, ECGC Policy.
• Processing of Purchase Bills of Raw Material, Assets & Passing Bills of expenses from various departments.

Overview:

We are seeking a highly motivated Regulatory Affairs Specialist to join our dynamic research Centre. The ideal candidate will have a strong background in regulatory requirements and compliance within the scientific research industry. This role plays a crucial part in ensuring that our research activities meet all applicable regulatory standards and guidelines.

Responsibilities:

• Develop and implement regulatory strategies to support research projects and product development initiatives.
• Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. 
• Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements.
• Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables.
• Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements.
• Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions.
• Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed.
• Participate in internal and external audits and inspections related to regulatory compliance.

Qualifications and skills:

• Bachelor’s degree in a science, pharmacy, or a related field; advanced degree (e.g., Master’s, PhD) preferred.
• Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry.
• Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation
• Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.
• Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.
• Proficiency in MS Office (Word, Excel, PowerPoint) and experience with regulatory software and databases.

Overview: We are seeking a strategic and results-driven Business Development Manager to join our dynamic team, focusing on expanding our Research and Development (R&D) initiatives. This role is pivotal in driving growth through identifying new opportunities, forging strategic partnerships, and enhancing our R&D capabilities.

 Responsibilities:

• Identify and pursue new business opportunities and partnerships within the R&D sector to drive revenue growth and expand market presence.
• Build and maintain strong relationships with key stakeholders including potential clients, partners, and collaborators in the scientific and research community.
• Lead the development and execution of strategic business plans and proposals tailored to R&D opportunities, including market assessments, competitive analyses, and financial modelling.
• Collaborate closely with internal R&D teams to understand capabilities, project pipelines, and technological advancements to align business development efforts with organizational goals.
• Negotiate and close agreements with external partners, including licensing agreements, joint ventures, and research collaborations.
• Track and analyze industry trends, market developments, and competitive landscape to identify emerging opportunities and potential threats.
• Represent the organization at industry conferences, networking events, and client meetings to promote our R&D capabilities and explore partnership opportunities.
• Prepare and deliver presentations and pitches to internal and external stakeholders, including senior management and potential clients.

Qualifications:

• Bachelor’s degree in a scientific discipline, engineering, business administration, or related field. Advanced degree (e.g., MBA, PhD) preferred.
• Proven experience (X years) in business development, strategic partnerships, or sales within the R&D sector, preferably in pharmaceuticals, biotechnology, or a related industry.
• Strong understanding of R&D processes, scientific research methodologies, and technological advancements.
• Excellent networking and relationship-building skills with the ability to engage with senior executives and decision-makers.
• Demonstrated ability to think strategically, analyze complex business opportunities, and develop innovative solutions.
• Exceptional communication skills, both verbal and written, with the ability to articulate technical and scientific concepts to diverse audiences.
• Proven track record of successfully negotiating and closing deals, with a strong business acumen and financial literacy.
• Ability to travel domestically and internationally as required.