Serán is seeking an Operations Specialist II who will play an integral role in the manufacturing of tablets, capsules and spray dried dispersions for use in early phase, clinical, FDA trials. Adhering to strict standard operating procedures (SOP) and following good manufacturing practices (GMP) are required. Position requires strong attention to detail and focus within a fast-paced and collaborative work environment. Employees exhibit teamwork, self-discipline, and proactive communication to ensure collective goals are achieved.
Duties & Responsibilities
- Strictly follows standard operating procedures (SOP).
- Complies with Good Manufacturing Practice (GMP).
- Completes documentation, including logbooks, batch records, and quality records.
- Revises documents for improved compliance and ease of use.
- Maintains an organized, clean, and stocked production area.
- Cleans tools, rooms, and equipment after use.
- Weighs, measures, subdivides, and disposes of product components.
- Safely handles and disposes of hazardous materials.
- Operates specialized machinery to manufacture pharmaceutical products.
- Training with other inner department teams.
- SME on particular process or equipment; interfaces with vendors or clients.
- Works closely and communicates effectively with operations team.
- Involved in safety and process improvement plans.
- Responsibilities may increase in scope to align with company initiatives.
Requires Skills & Knowledge
- Proficient understanding of pharmaceutical manufacturing processes, requires minimal instruction.
- Self-motivated.
- Ability to instruct or train others.
- Mechanical aptitude.
- Strong verbal and written communication skills.
- Strong organization skills and attention to detail.
- Proficient in basic math.
- Strong time management skills with ability to meet deadlines.
- Ability to prioritize and ask for assistance to delegate tasks when appropriate.
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the company.
- Demonstrated ability to collaborate and work in cross-functional teams.
- Ability to focus in a fast-paced environment with shifting priorities.
- Proficient with Microsoft Office Suite or related software.
- Accepts feedback from a variety of sources and constructively manages conflict.
Education & Experience
- High School Diploma or equivalent.
- Coursework or experience in chemistry or manufacturing field preferred.
- Approximately 2 years of GMP experience.
Physical Requirements
- Prolonged periods of sitting or standing while monitoring equipment.
- Must be able to lift up to 25 pounds regularly, and up to 55 pounds occasionally.
- May require ability to work swing or weekend shift with the possibility of 12-hour shifts.
- Must be able to wear a Tyvek suit with PAPR for extended periods of time.
- Exposure to constant low-level equipment noise, and occasional high-level alarms.
- Work near heat generating equipment.
- Move up and down ladders, kneel, squat, balance on one foot.
- Move mop above head while cleaning room surfaces.
- Adheres to consistent and predictable in-person attendance.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
