Manufacturing Scientist

  The Role We are looking for a Manufacturing Scientist to join our team in Garnet Valley. In this role, you will play a key part in supporting both lab‑scale formulation development and clinical‑stage GMP batch manufacturing. You will work hands‑on with a wide range of pharmaceutical dosage forms and contribute directly to the development and manufacture of products that support clinical trials and ultimately impact patient outcomes.   Key Responsibilities Conduct lab work as planned by the supervisor that involves development of pharmaceutical formulations such as tablets, capsules and liquids. Conduct pharmaceutical manufacturing of oral dosage forms using small to large scale equipment for development and process scale up and for clinical supplies. Review and write master batch records with input from supervisor. Prepare executed batch record folders. Comply with cGMPs, SOPs and Company policies. Operate manufacturing equipment’s with Operator for development clinical manufacturing. Maintain planned training schedule and record. Completion of clinical batch manufacturing as per timeline Ability to perform physical work while using a respirator.   Additional Tasks/responsibilities Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.  Complies with all company and site policies and procedures. Remains current in profession and industry trends. Makes a positive contribution as demonstrated by: Making suggestions for improvement Learning new skills, procedures and processes. Is available for other duties as required.   Qualifications and Experience Required for Competent Performance B.S. Degree in Chemical Engineering, Pharmacy/Pharmaceutical Sciences or other related field or High School Diploma with 2-3 years’ experience in the pharmaceutical industry or appropriate combination of education and experience Read and interpret documents such as batch records, SOPs, policies, and safety rules, read and write business correspondence. Define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Basic knowledge of physicochemical concepts and theories. Familiarity with the production process. Familiar with a variety of in-process equipment, such as disintegration, friability, particle size, etc.   Computer skills: Enter data into computer using software applications for data entry and word processing. Work and be proficient with e-mail systems Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production. Apply basic concepts such as fractions, percentages, ratios, proportions and significant figures to practical solutions. Work with basic statistical concepts such as average and standard deviation. Skills: The effective use of knowledge and abilities in performance. Read and interpret documents such as RFP’s (request for proposals) Analytical methods, Formulation reports, MSDS’s, SOP’s (Job Standard Operating Procedures).  Write routine reports and business correspondence, work orders, etc. Ability to communicate effectively with Internal and External resources.   Abilities:  Innate traits or talents a person possesses Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.  Define problems, collect data, establish facts and draw valid conclusions. Experience in the pharmaceutical industry. Experience with the contract pharmaceutical services industry.   Computer skills: Enter data into computer using software applications (I.e. Salesforce or equivalent) for data entry and word processing. Work and be proficient with e-mail systems Ability to perform multitude of tasks while maintaining speed of work and attention to detail without loss to productivity. Ability to perform under stress in cases of emergency, critical or hazardous situations. Ability to work with others in a team environment. Ability to travel 50%   Work Schedule M-F 08:00 – 16:30 This role is classified as Exempt   Physical Demands   In this role a person must be able to complete the following… Remain in a stationary position 50-75% of working time Occasionally walk, traverse, inside the office to attended meetings, file paperwork, or manipulate office technology (printers, technology, physical documents) Continuously operate a computer or other office machinery (calculator, phone, copy machine, or printer) Communicate information and ideas so others will understand.  Must be able to exchange accurate information written and verbally. Occasionally work outside the typical Work Schedule