Pharmaceutical Manufacturing Technician

Supernus Pharmaceuticals, Inc.; Rockville (MD); On-site; USD 48,000 - 55,000; Full time

Job summary

Supernus Pharmaceuticals is seeking a Pharmaceutical Manufacturing Technician to support drug product development and manufacturing by operating, setting up, cleaning and maintaining pharmaceutical processing equipment and manufacturing areas.

You will execute batch records, prepare processing suites for R&D and GMP operations, maintain supplies, document activities, and support studies under direction of scientists and manufacturing leadership.

Qualifications

• High school diploma or equivalent with 1+ years in pharmaceutical GMP manufacturing, drug product development, laboratory operations or related experience.
• Associate degree in Pharmaceutical Technology, Biotechnology, Chemistry, Biology, Engineering Technology or related field preferred.
• Experience in a cGMP environment is desirable.
• Knowledge of GMP concepts, practices, and procedures in the pharmaceutical industry is preferred.
• Familiarity with solid dosage form manufacturing processes such as encapsulation, tablets, fluid bed processing, and coating is 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 and time-management skills.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Set up, operate, monitor and tear down pharmaceutical manufacturing processing equipment.
• Prepare processing rooms and equipment for R&D, pilot-scale and GMP manufacturing operations.
• Execute manufacturing operations in accordance with batch records, SOPs, and cGMP.
• Perform equipment cleaning and room turnover to ensure readiness for operations.
• Assist with equipment troubleshooting and maintenance in collaboration with engineering teams.
• Support technology transfer, scale-up and process development activities.
• Record observations and document results in real time.
• Report deviations, equipment issues, and operational concerns promptly.
• Maintain cleanliness and organization of suites, labs, and equipment.
• Coordinate ordering and replenishment of materials and consumables as needed.
• Assist scientists with process development and characterization studies.
• Follow all safety procedures and cGMP regulations.

Skills

Attention to detail

Documentation

Teamwork

Independent work

Education

High School Diploma or equivalent

Associate degree in Pharmaceutical Technology

Tools

Microsoft Office

Electronic documentation systems

GMP equipment

Job description

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Pharmaceutical Manufacturing Technician supports drug product development and manufacturing activities by operating, setting up, cleaning, and maintaining pharmaceutical processing equipment and manufacturing areas. This position is responsible for executing batch records, preparing processing suites for R&D and GMP operations, maintaining laboratory and manufacturing supplies, documenting activities accurately, and supporting scientific studies and manufacturing campaigns under the direction of scientists and manufacturing leadership.

Essential Duties & Responsibilities:

• Set up, operate, monitor and tear down pharmaceutical manufacturing processing equipment used in the 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.
• Participating in training programs and maintaining required qualifications for assigned responsibilities.

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• High School Diploma or equivalent 1+ 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 but not limited to 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.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have an innovative and dynamic approach to work.
• A 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.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel 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, when working in the lab.
• The employee is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is also required to have the visual acuity to perform activities such as operating machines, and to perform mechanical or skilled trade tasks of a non-repetitive nature.
• Will be required to work in GMP processing room environment that requires wearing personal protective equipment to include but not limited to; 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.
• The employee is not substantially exposed to adverse environmental conditions on a regular basis. Employee may have to wear Tyvek suits when working in the development labs or GMP suites, which can make conditions warmer, and more challenging. Employee will be required to work and exert force while wearing Tyvek suits.

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $48,000 to $55,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.