What are the responsibilities and job description for the Manufacturing Associate position at PSC Biotech?
The work we do at BioTechnique has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join BioTechnique and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At BioTechnique, you determine what’s possible.
BioTechnique® is a highly potent sterile injectable and clinical oncolytics manufacturing company dedicated to providing cytotoxic and high potency sterile injectable fill-finish services. BioTechnique’s project management and client services staff work closely with our clients to meet all manufacturing needs. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and optional lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to work with our clients to create a process design for their product that suits their needs.
The Experience
With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At BioTechnique, it’s about more than just a job—it’s about your career and your future.
Your Role
This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMP/ISO requirement and standards. With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in aseptic and non-aseptic filling, equipment prep, cleaning dissolution and formulation activities. The individual may provide support in other departments within the company, including but not limited to, engineering, warehouse and facilities.
- Maintain and adhere to safe work habits and all applicable safety procedures and guidelines
- Execute manufacturing instructions to perform equipment preparation, compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs
- Strong adherence to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes all appropriate production documentation
- Identifies, escalates, and documents events that deviate from normal operation; participate as needed in investigations. Assist in the introduction of manufacturing schemes into the GMP manufacturing facility
- Assist with the formulation and validation of new processes with the assistance of the tech transfer group
- Execution of all routine and critical operations as well as commissioning and validation activities, as assigned.
- Revise and author Standard Operating Procedures (SOPs)/Batch Records.
- Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.).
- Ensure sanitization and sterilization practices (build, clean, sanitize and sterilize equipment and components to support production operations)
- Responsible for floor inventory and communicating schedule changes, as needed, to supervisor
- Recommend/Implement process changes/improvements or safety/ergonomic improvements
- Perform room sanitization activities to maintain controlled environment conditions
- Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause and implement appropriate corrective actions
- Assist supervisor/engineer/facilities with investigations and communicate any quality issues/concerns to Supervisor and QA. Interacts with cross functional support teams, such as Quality Assurance, Quality Control, Engineering, R&D, Validation, etc.
- Ensure general knowledge of aseptic techniques and maintain certification for aseptic gowning and demonstrate the ability to perform duties utilizing proper aseptic technique
- Perform and ensure COP, CIP, and SIP operations are performed to prepare equipment
- Support engineering, warehouse and facilities departments to gain cross-functional skills, as required.
- Additional duties as required.
Benefits
Offering a full suite of benefits, BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Equal Opportunity Employment Statement:
BioTechnique is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Education in Biology, Chemistry, Biotechnology, or related. 1-3 years professional experience in the FDA Regulated Pharmaceutical, Life Sciences, and/or Engineering field. Experience within GMP Manufacturing Pharmaceuticals and/or cGXP/ISO environment. Willingness to work extended shifts and a variable schedule when required. Experience with sterile injectables drugs preferred. Familiarity with formulation, filling, primary packaging, and aseptic processing. Strong knowledge of aseptic techniques preferred. Flexible individual with good written and verbal communication skills. Excellent communication and organizational skills. Experience in reviewing and creating controlled documents. MS Office/Excel tools experience. Self-motivated individual with the ability to complete and manage multiple floor activities in an effective and compliant manner. In the absence of the supervisor, they are the person of authority. Attention to detail with strong mechanical aptitude. Positive attitude and strong interpersonal skills. Strong ability to plan and prioritize complex activities. Strong analytical skills to identify risks and prepare balanced decisions. Ability to lift 25-40 lbs.