Director of Formulation & Transfer
Proclinical is seeking a Director of Formulation & Transfer for a leading pharmaceutical company located in Hunt Valley, MD.
The Director of Formulation & Transfer will provide technical guidance to the R&D and tech transfer team to ensure transferability of formulations to the GMP environment for all products from pre-clinical to commercialization. The director will also lead a team of formulation associates to ensure successful formulation of bulk product.
Must be eligible to work in the US.
- Provide leadership to Formulation Associates of various levels. Responsibilities include hiring, managing, motivating, coaching, and mentoring.
- Ensure oversight and leadership of Formulation across all shifts, including weekend support as needed.
- Manage API/Excipients weigh/dispense/production suites, clean/sterile assembly preparation, cleaning and sanitization of production suites and raw material sampling and dispensing.
- Drive the design, acquisition, and implementation of new formulation technologies.
- Support Tech transfer team with the transfer of new APIs, excipients, or raw materials.
- Work closely with R&D and the tech transfer team to support the development of formulations to ensure transferability into GMP environment, adequately and compliantly.
- Lead routine formulation activities, including day-to-day scheduling for timely formulations.
- Ensure accurate documentation of data and completion of batch records as needed.
- Perform and train other employees in Formulation Operations.
- Ensure personnel is trained on all applicable procedures and master batch records prior to execution.
- Initiate revisions to cGMP procedures, and master batch records.
- Lead and/or participate in problem solving of formulation challenges with internal and external stakeholders.
- Identify and implement formulation and process improvements with R&D team for new and existing products.
- Interface with auditors, including client representatives and regulatory agencies.
- Support Agency, customer, and vendor audit as needed.
- Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Lead development of standards including system, tools, and templates across site for technology transfer through validation related activities.
- Promote knowledge management and sharing of best practices related to tech transfer, formulation development and validation across sites.
- Use sound judgment and data analysis skills to resolve problems and make routine and advanced decisions independently.
- Prepares CMC section content for applicable regulatory submissions.
- Perform other duties as assigned.
Skills and Requirements:
- A degree (Bachelor to Ph.D.) in a related field with a minimum of 8 years relatable experience, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- Strong formulation background is required.
- Experience working in the aseptic manufacturing industry is preferred.
- Solid technical background across a variety of scientific disciplines and fundamentals (manufacturing process technologies, biopharmaceutical best practices, lyophilization, formulation development, validation, statistical analysis, regulatory submissions, etc.)
- Experience in managing scientists/engineers in a fast paced, challenging environment.
- Strong knowledge of lean principles in a manufacturing environment with successful application experience
- Diverse and demonstrated technical knowledge with strong risk management mindset.
- Strong technical and communication skills: oral/written and listening.
- Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
- Demonstrate a proven track record of management and leadership effectiveness.
- Fundamental understanding of budget management including both OPEX and CAPEX forecasting and planning.
- Demonstrate the ability to accommodate non-routine work schedules, and be able to respond to call-ins.
- Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
- Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
- Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Demonstrate good understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrate the ability to portray the appropriate level of integrity and professionalism.
- Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
- Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
- Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results-oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
If you are having difficulty in applying or if you have any questions, please contact Jessika Rodriguez at +(1) 617-391-0929 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.