Pharmaceutical Manufacturing Technician

About the role

Supports drug product development and manufacturing activities by operating, setting up, cleaning, and maintaining pharmaceutical processing equipment and manufacturing areas. Executes batch records, prepares processing suites for R&D and GMP operations, maintains laboratory and manufacturing supplies, documents activities accurately, and supports scientific studies and manufacturing campaigns under the direction of scientists and manufacturing leadership.

Responsibilities

• Set up, operate, monitor and tear down pharmaceutical manufacturing processing equipment used in drug product development and manufacturing activities.
• Prepare processing rooms and equipment for R&D, pilot-scale and GMP manufacturing operations.
• Execute manufacturing operations in accordance with approved batch records, standard operating procedures (SOPs), and current Good Manufacturing Practices (cGMP).
• Perform equipment cleaning, room clearance, and room turnover activities to ensure readiness for manufacturing operations.
• Assist with equipment troubleshooting maintenance activities in collaboration with engineering personnel, vendors, and equipment service providers.
• Support technology transfer, scale-up and process development activities as assigned.
• Execute batch records, logbooks, forms, and support manufacturing documentation accurately and in real time.
• Record detailed observations during manufacturing development and experimental activities.
• Report deviations, equipment issues, and operational concerns to management promptly.
• Maintain cleanliness and organization of manufacturing suites, laboratories, equipment, and support areas.
• Perform routine cleaning and sanitization activities according to approved procedures.
• Maintain inventory of laboratory, manufacturing, and cleaning supplies.
• Coordinate ordering and replenishment of materials and consumables as needed.
• Collect, document and communicate experimental observations and results accurately.
• Assist scientists with process development, formulation development, equipment evaluations and process characterization studies.
• Follow all company safety procedures, environmental health and safety requirements and cGMP regulations.
• Maintain a safe, compliant and inspection-ready work environment.
• Participate in training programs and maintain required qualifications for assigned responsibilities.

Requirements

• High School Diploma or equivalent.
• 1+ years of Pharmaceutical GMP manufacturing, drug product development, laboratory operations, packaging, or comparable experience.
• Associate degree in Pharmaceutical Technology, Biotechnology, Chemistry, Biology, Engineering Technology or a related scientific field preferred.
• Experience working in a cGMP environment is desirable.
• Knowledge of GMPs and other commonly used concepts, practices, and procedures within the pharmaceutical industry preferred.
• Knowledge of solid dosage form manufacturing including encapsulation, manufacture of compressed tablets, fluid bed processing, high shear granulation, tablet coating, blending, etc., preferred.
• Ability to follow written procedures, batch records, and scientific protocols.
• Familiarity with pharmaceutical processing equipment and manufacturing operations.
• Strong attention to detail and documentation practices.
• Ability to identify and communicate processes, equipment, and quality concerns.
• Strong organizational skills and time-management skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Basic troubleshooting and problem-solving abilities.
• Proficiency with Microsoft Office applications and electronic documentation systems preferred.
• Working knowledge of safety, health, and environment regulations, including the proper handling of chemicals, hazardous materials, waste disposal, and the use of personal protective equipment (PPE).
• Ability to write and adhere to internal written procedures.
• Ability to work with hazardous waste and laboratory chemicals.
• Authorized to legally work in the United States without visa sponsorship.

Other Characteristics

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Innovative and dynamic approach to work.
• Self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.

Physical Requirements

• When in the development labs or GMP suites, employees will be required to exert up to approximately 50 pounds of force occasionally and/or up to 30 pounds of force frequently, as well as exert up to 10 pounds of force constantly to move objects.
• Close visual acuity to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• Visual acuity to perform activities such as operating machines and performing mechanical or skilled trade tasks of a non-repetitive nature.
• Required to work in GMP processing room environment that requires wearing personal protective equipment including gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits.
• May have to wear Tyvek suits when working in the development labs or GMP suites, which can make conditions warmer and more challenging.
• Required to work and exert force while wearing Tyvek suits.

Pay

The expected salary range for fully qualified candidates applying for this role is $48,000 to $55,000. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, including education, relevant experience, knowledge, length of industry experience, and organizational needs.

Benefits

• Health, dental, and vision insurance.
• Paid time off.
• 401k company match.
• Company paid life insurance.
• Health and wellness benefits.
• Stock equity awards.
• Employee stock purchase program.
• Participation in the Company’s discretionary annual bonus program.