Now Hiring - Healthcare Product Development Manager in Santa Ana, CA

Job Description - The Pharmaceutical Product Development Manager

This position reports to the Vice President of Operations.

The Pharmaceutical Product Development Manager will oversee and be responsible for Product Development of commercial Drug Products for McGuff Pharmaceuticals, Inc. The scope of responsibilities includes managing the product development process from initial Idea Generation through Product Launch.

The Product Development Process includes stages identified as

· “Idea Generation” - identifying and researching potential Markets (current and new), customers, and potential Drug Product candidates that meet the Company’s overall strategic goals,

· “Feasibility and Proposal Presentations” - working with Senior Management to present for approval select Drug Products for further development,

· “Formulation Development” – Creating a discrete Product Development Project to devote additional resources to Product and Process development activities

· “Product and Process Scale-up” – Work with the company’s Engineering, Quality and Production groups to plan and implement final process and product specification and scale up requirements to meet validation and manufacturing requirements,

· “Registration and Listing” - working with MPI’s Regulatory Affairs group to prepare and submit required registration and listing,

· “Product Launch” – working with MPI’s Production, Engineering, and Marketing/Sales groups, as well as the Company’s Senior Management, to ensure proper and efficient manufacturing and timely product lunch to designated markets and channels.

The job includes identifying product development Drug Product candidates that meet strategic objectives for McGuff Pharmaceuticals, Inc. and, in turn, managing all Product Development projects and activities for McGuff Pharmaceuticals injectable products produced, primarily through Aseptic manufacturing processes. Interact with Key Opinion Leaders (KOL) and cultivate business opportunities and client relationships. Develop, implement and continuously improve the product development processes for the organization. Ensure written procedures and other documents exist for appropriate development activities. Executes tasks related to the company’s product development protocols and ensures formulation and process development activities as well as product transfer and support are accomplished to meet strategic objectives.

The Pharmaceutical Product Development Manager provides technical insight, guidance, and coaches product development staff in areas such as idea generation, product selection, , project planning, product research, formulation and product/process development , and analytical methods. Manage multiple product development projects, . Interfaces with other departments to progress project, as needed. Helps to manage and facilitate information flow including product development records, literature, intellectual property, contracts and relevant documentation.

The Pharmaceutical Product Development Manager will develop and work closely with Key Opinion Leaders (KOLs), customers, company personnel and company management to ensure all applicable policies and procedures, state and federal laws, and ICH requirements for Drug development are met.

Essential functions and duties shall include:

• Responsible for coordinating and implementing activities related to future and ongoing product development including:
• Build and maintain core product development teams within the company.
• Developing and implementing systems for Drug Product idea generation and feasibility analysis
• Implementing departmental policies, programs and procedures for product development.
• Identify and present for senior management review candidate Drug Products for potential development based on market and company capability measures.
• Plan, organize and lead multiple product development projects; including identifying goals, objectives, methods, resources, and routes of communication needed to carry out responsibilities and dates for completion of product development activities and tasks.
• Organizing resources to achieve the goals in an optimum fashion.
• Establishing effective communications and guiding project teams to accomplish stated project objectives.
• Coordinating and managing assigned product development and engineering activities.
• Implementing the Company’s Process and Product Development procedures for targeted products to ensure finished products meet the required safety, identity, strength, quality and purity they purport to possess. This includes developing and defining user requirement (e.g. finished product specifications), material specifications, process input specifications, process parameter specifications, process output specifications, product specifications, procedures, and controls.
• Provide managerial and technical guidance to department staff as required in areas related to product development such as characterization, pre-formulation, formulation and process development, scale-up, preparing clinical supplies, technology transfer, manufacturing scale-up, and formulation and process improvement, and product commercial launch.
• Troubleshoot, conduct failure analysis and corrective action of design and process challenges
• Working with Manufacturing, Engineering, Quality Systems and other personnel to ensure anticipated product development activities and outputs are planned and effectively executed.
• Coordinating product and process engineering, qualification, and validation studies, as needed.
• Assure that product development activities comply with all regulatory and compliance requirements (e.g. NDA, ANDA, IND requirements)
• Working with Key Opinion Leaders (KOLs), customers and clients to define and implement Drug Product candidates and to identify and work on Business to Business opportunities (e.g. contract manufacturing opportunities) to meet customer requirements and exceed expectations.
• Working with customers and other employees to develop implement and control clinical trials.
• Other duties as assigned.

Minimum qualifications shall include:

• Education: Bachelor of Science in Engineering, Chemistry, Biology or related field degree. Advanced technical degree is a plus: MBA, Masters of Science, or PhD Degree.
• Minimum of 10 years relevant industry experience. Prefer minimum of 7 years relevant pharmaceutical industry experience with a portion of that experience in product development of injectable drugs produced by aseptic processes.
• Experience with regulated industry Product Development and Regulatory requirements.
• Familiar with Chemistry, Engineering and Manufacturing operations.
• Knowledge of state, federal, and international regulatory requirements and submissions (Federal marketing application such as NDA, ANA, IND, PMA, etc…) for Pharmaceutical (or medical device) products.
• Thorough understanding and application of technical principles, theories, and concepts related to product, process, technology development and evaluation.
• Understanding and working knowledge of chemical and physical properties of pharmaceutical active ingredients and excipients as they relate to formulation, process and drug delivery.
• Working or theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment, and drug delivery systems.
• Ability to develop or collaborate on formulation development, manufacturing processes, and pharmaceutical products.
• Working understanding of statistical techniques including experimental design.
• Knowledge of FDA and International Conference on Harmonization (ICH) guidance affecting drug product development (e.g. FDA Patient-Focused Drug Development Guidance for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making ICH Q1 to ICH Q14, etc…)Computer literate and familiar with computerized inventory monitoring, tracking and control systems.
• Type a minimum of 45 words per minute.

What is expected from you:

• Appropriate professional demeanor.
• Acquire knowledge of and assure compliance to corporate policies and procedures.
• Ability to work with others.
• Excellent communication skills.
• Work with all McGuff employees to foster and promote quality.
• Excellent customer skills
• High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
• High sense of Responsibility, Ownership, Accountability.
• Capable of Flexibility in work requirements/conditions and willingness to embrace change
• Results driven.

Why work for McGuff Family Companies, Inc.?

At McGuff Pharmaceuticals, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, vision, life insurance and 401K retirement plans. In addition, McGuff values its employees and their life outside of work, which is why we offer all employees generous vacation and personal days off!

Job Type: Full-time

Pay: $80,000.00 - $170,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Work Location: One location