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BioPharma R&D Drug Product Development / Project Manager

McGuff Family of Companies Orange County ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description: IntroMcGuff 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 errorsWorking 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‐FocusedDrug 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 skillsHigh 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 changeResults 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. Company Description: We are a family company that has been in business for 35+ years located in Santa Ana California. We have three companies located in Southern California who are all seeking dedicated, hard working, candidates who bring a smile to work every day. History: Apollo 16 astronauts were walking on the moon when Gilbert J. McGuff (Gil), decided to supplement his income by supplying innovative medical products to Bariatric physicians and patients. Gil founded the McGuff Company (McGuff) in 1972 and became its sole proprietor. While working fulltime and managing McGuff after hours, Gil still found the time to instill an entrepreneurial spirit in all three of his sons. Each son eventually started his own business. In 1979 Gil was approaching retirement and sold McGuff to his youngest son Ronald M. McGuff (Ron) who had been working for Procter & Gamble. Gil was hired by Ron as the first company employee and both Ron and Gil worked hard together to build upon McGuff’s early success as a nation-wide distributor of medical products. Ron’s first day working for the new McGuff was April 1st 1979. A new direction was taken to align the company with the medical profession’s leading innovators in complementary medicine. Understanding the needs of these extraordinary physicians became paramount for McGuff. The McGuff team visited complementary physicians around the country to understand the unique therapies provided to patients. McGuff molded itself to provide these physicians with the unique products they desired. McGuff was incorporated in 1982 and remains a family owned company. McGuff developed associations with the industry’s leading manufacturers to bring quality drugs and medical devices at discounted prices to complementary physicians. McGuff developed a number of services and products to address specific needs of physicians and patients. Among these innovations; Ascorbic Acid injection with EDTA (replacing Monothioglycerol), Osmolarity Software, EDTA dose calculating software, IV administration sets with internal filters, and McGuff/physician computerized inventory control, etc.

McGuff Family of Companies

Why Work Here?

Awesome CEO, Great Benefits, Room for growth

We are a family company that has been in business for 35+ years located in Santa Ana California. We have three companies located in Southern California who are all seeking dedicated, hard working, candidates who bring a smile to work every day. History: Apollo 16 astronauts were walking on the moon when Gilbert J. McGuff (Gil), decided to supplement his income by supplying innovative medical products to Bariatric physicians and patients. Gil founded the McGuff Company (McGuff) in 1972 and became its sole proprietor. While working fulltime and managing McGuff after hours, Gil still found the time to instill an entrepreneurial spirit in all three of his sons. Each son eventually started his own business. In 1979 Gil was approaching retirement and sold McGuff to his youngest son Ronald M. McGuff (Ron) who had been working for Procter & Gamble. Gil was hired by Ron as the first company employee and both Ron and Gil worked hard together to build upon McGuff’s early success as a nation-wide distributor of medical products. Ron’s first day working for the new McGuff was April 1st 1979. A new direction was taken to align the company with the medical profession’s leading innovators in complementary medicine. Understanding the needs of these extraordinary physicians became paramount for McGuff. The McGuff team visited complementary physicians around the country to understand the unique therapies provided to patients. McGuff molded itself to provide these physicians with the unique products they desired. McGuff was incorporated in 1982 and remains a family owned company. McGuff developed associations with the industry’s leading manufacturers to bring quality drugs and medical devices at discounted prices to complementary physicians. McGuff developed a number of services and products to address specific needs of physicians and patients. Among these innovations; Ascorbic Acid injection with EDTA (replacing Monothioglycerol), Osmolarity Software, EDTA dose calculating software, IV administration sets with internal filters, and McGuff/physician computerized inventory control, etc. The McGuff Company evolved to meet changing needs of complementary physicians and new therapies that they have developed. McGuff’s reputation for quality products, excellent customer support and regulatory integrity became known to a broad spectrum of physicians in the United States and around the world. For more information about each of the specific companies please read below: McGuff Pharmaceuticals, Inc. McGuff, anticipating profound changes to the regulation of injectable drugs, chose to launch a second wholly owned subsidiary, McGuff Pharmaceuticals, Inc. (MPI) in 2002. McGuff Pharmaceuticals, Inc. is a Food and Drug Administration inspected sterile fill manufacturer that maintains a tradition of quality and a core competency in both current Good Manufacturing Practices (cGMP), representing a unique combination for any pharmaceutical manufacturer. MPI sustains McGuff’s efforts to assure physicians a steady supply of FDA approved drugs through its own drug development program. MPI also provides contract manufacturing organization (CMO) services, contract development and manufacturing organization (CDMO) services and is international in it scope. MPI continues the McGuff tradition of providing personalized services, great customer care and the knowledge to be a valued member of any CMO or CDMO team. MPI maintains offices in the United States and Canada Website: www.mcguffpharmaceuticals.com

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4040 W Carriage Dr
Orange County, CA
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