BioPharma New Drug Product Development Manager
McGuff PharmaceuticalsSanta Ana, CA2 months ago
Intro
McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered company with a reputation for outstanding commitment to quality and customer satisfaction.
As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.
Job
This position reports to the Vice President of Operations.
The Sterile Drug - Pharmaceutical Product Development Manager will oversee and be responsible for all cGMP Sterile Drug Engineering, Manufacturing and Facilities. A subject matter expert. Identifying product development candidates and, in turn, managing all Product Development projects and activities for McGuff Pharmaceuticals sterile injectable products produced, primarily through Aseptic manufacturing processes. Identify and recommend products for development that meet strategic objectives for McGuff Pharmaceuticals, Inc. 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. Provides technical insight, guidance, and coaches product development staff in areas such as product selection, safety, project planning, product research, product/process development and application, and analytical techniques. Manage the product development projects, as assigned, with regards to materials, equipment, operating procedures and compliance to company policies. Interfaces with other departments as needed to progress projects. Helps to manage and facilitate information flow including product development records, literature, intellectual property and relevant documentation. He/she will 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 are met.
Duties shall include:
  • Responsible for coordinating and implementing activities related to future and ongoing product development including:
  • Implementing departmental policies, programs and procedures for product development.
  • Identify and present for senior management review candidate products for development based on market and company capability measures.
  • Plan, organize and lead 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 a project teams to accomplish stated project objectives.
  • Coordinating and managing assigned product development and engineering activities.
  • Meeting strategic objectives for company growth.
  • Process and Product Development 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 material specifications, process input specifications, process parameter specifications, process output specifications, product specifications, procedures, and controls.
  • Provides 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.
  • Troubleshooting, failure analysis and corrective action of design and processing errors
  • Working with Manufacturing, 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.
  • Assurance 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 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.
Qualifications include:
  • Education: Bachelor of Science in Engineering 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 sterile 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 and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment, advanced technologies, and delivery systems.
  • Ability to develop formulations, 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, ICH Q1 to ICH Q14, etc…)
  • Knowledge of FDA requirements and guidance (e.g. new product development, cGMP and marketing applications)
  • Computer literate and familiar with computerized inventory monitoring, tracking and control systems.
  • Type a minimum of 45 words per minute.
Expectations:
  • 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 Family Companies, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Family Companies, Inc. provides a comprehensive benefits package that includes medical, dental, vision and 401K retirement plans. In addition McGuff values it’s employee’s and their life outside of work too, which is why we offer all employees 11 paid days off per year!
Not to mention, we are growing fast and new opportunities emerge every day. McGuff offers a supportive setting where you can take control of your career while still enjoying the mentorship to develop new skills in an environment where you have an opportunity to thrive.
Want to learn more? Submit your resume now.
Job Type: Full-time
Pay: $33.00 - $80.00 per hour
Benefits:
  • 401(k)
  • 401(k) Matching
  • Dental Insurance
  • Flexible Schedule
  • Health Insurance
  • Paid Time Off
  • Vision Insurance
Schedule:
  • Monday to Friday
Experience:
  • Aseptic Sterile Manufacturing: 6 years (Required)
  • Injectable Drug Products: 6 years (Required)
  • BioPharmaceuticals / Product Development: 6 years (Required)
  • Engineering: 6 years (Required)
Education:
  • Bachelor's (Required)
Location:
  • Santa Ana, CA 92704 (Required)
Work authorization:
  • United States (Required)
Company's website:
  • mcguff.com
Work Remotely:
  • No
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