BioPharmaceutical Formulation Scientist / Product Development Manager
Job Description
JOB DESCRIPTION
This position reports to the Vice President of Operations.
The Sterile Injectable 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.
ESSENTIAL FUNCTIONS AND DUTIES SHALL INCLUDE:
MINIMUM QUALIFICATIONS SHALL INCLUDE:
WHAT IS EXPECTED FROM YOU:
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. 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