Manufacturing Science Associates/Supervisors

Summary of Position

"Quality and safety above everything". That is the unassailable theme that guides everything that we do, every day. We have an unwavering commitment to quality and the production of safe and effective products. Our science and risk-based compliant quality culture is flexible, innovative, and healthcare oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact our success.

Pherros Biosciences has built a completely new, inspiring, environmentally conscious, and highly automated facility in Deerfield Beach, Florida. This brand-new facility will utilize state of the art technology to engage in parenteral (injectable) pharmaceutical production and packaging operations. This is an exciting and once-in-a-lifetime opportunity to help initiate and operate a new site.

There are numerous positions available for entry, mid-level and supervisory roles in manufacturing operations. The Manufacturing Science Associate will engage in various aspects of pharmaceutical production, including formulation, aseptic filling, visual inspection and secondary packaging, as well as equipment and process implementation activities required to bring the facility into service. Manufacturing Science personnel will be responsible for ensuring continuous supply of our medicines by expertly running the processes, troubleshooting, collaborating cross-functionally, and adhering to our safety first / quality always mindset. Senior and lead Manufacturing Science personnel will coordinate daily activities to meet capacity plans while developing their own as well as the team's capabilities.

A Manufacturing Science Supervisor is expected to have experience in performing the responsibilities of a Manufacturing Science Associate but also provide daily supervision of areas within manufacturing, maintain responsibility over production timelines and achieve department goals. This includes process planning activities, setting schedules, coordinating interactions and services from other internal and external groups, and assigning daily work tasks. Additional responsibilities will be hiring, development, coaching/leading, and training of manufacturing operators in the assigned area.

Your Diligence Means Our Success

You will be a member of Pherros' dedicated and highly effective manufacturing operations team. You will evaluate, review and engage in the manufacturing and production of life-changing pharmaceuticals. It is your problem-solving skills that will make us ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

As a Manufacturing Science Associate, you will be part of a team that will execute batch release processes in the course of internally manufactured products. You will ensure drug product manufacturing is carried out in a compliant manner in accordance with current Quality Standards and current Good Manufacturing Practices (cGMPs). Additional specific responsibilities include:

• Engagement in operations on the manufacturing floor ensuring high level of safety, quality, and productivity to maintain production and a reliable supply of products to patients.
• Responsibility for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting manufacturing and safety goals.
• Setting a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
• Being a technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
• Engaging in manufacturing investigations and implementing corrective and preventative action ("CAPA") plans.
• Operating the equipment and performing activities as required to meet production schedule.
• Completing and assisting in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
• Driving key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
• Supporting Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls.
• Acting as a liaison between operations and support functions.

The responsibilities of a Manufacturing Science Supervisor would include those of a Manufacturing Science Associate, and:

• Ensure production activities comply with cGMP guidelines. Follow all documentation and standard operating procedures. Set priorities, process execution, work assignments, and reprioritize as required.
• Responsibility for providing support to their respective process team.
• Responsibility for cGMP compliance, ensuring that all production equipment is properly validated, and procedures are maintained within validated state.
• Author and revise standard operating procedures and batch records. Review technical reports. Conduct deviation investigations and write process deviation reports.
• Ensure that all production equipment is properly maintained, production areas are inspection ready, and production processes meet quality standards.
• Train personnel in manufacturing process/operations following standard operating procedures and cGMP guidelines.
• Measure and appraise operator performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations.
• Serve as a manufacturing advocate in cross functional meeting and champion company policies to area staff.
• Contribute and adhere to safety, environment, and quality of the Company.
• Communicate safely and maintenance problems., status of operations, and employee-related issues in a timely manner to management.

Qualifications

Must-Have

• We have several levels open for Manufacturing Science Associates and Supervisors which are based on the experience and education you bring.
• Minimum education: Bachelor's Degree in a scientific discipline such as Biology, Biochemistry, Chemistry or other related discipline, or a High School Diploma/GED equivalent with more than five (5) years of relevant work experience.
• Ability to effectively communicate (electronically, written and verbal)
• Flexibility - the ability to troubleshoot and triage challenges
• Computer proficiency (desktop and tablet software, MS office, quality management system ("QMS")).
• Must pass a vision exam and be free of color blindness
• Must be equivalent to 20/20 correctable close vision acuity
• Must Pass a "fitness for duty" physical exam
• When in full operation, must have the ability to accommodate longer shifts on a rotating basis when necessary
• Ability to work overtime as required
• Ability to wear safety equipment (glasses, gowns, shoes, gloves, head and face covers, etc.)
• Ability to work and gown in a cleanroom (Grade A-D, Class 100,000 – Class 100; ISO 5 - ISO 8) environment.
• Qualified candidates must be legally authorized to be employed in the United States.
• Pass routine drug-testing suitable for manufacturing personnel.
• Must meet the physical requirements of the job; must have the ability to:
• Lift a minimum of 30 lbs.
• Bend, reach, stretch, climb ladders, and work in tight spaces.
• Stand for long periods.

Nice-to-Have

• (Senior and Lead roles) Leadership and the ability to train / educate team members
• STEM degree or certifications
• Aseptic filling, single use assemblies, isolator technology.
• Automated, semi-automated, and/or manual inspection.
• Knowledge of current Good Manufacturing Practices (CGMPs)
• Experience in operations or manufacturing environments.
• Pharmaceutical, medical device or food processing industries
• Manufacturing Execution Systems and electronic batch release.
• Continuous improvement (Lean, Six Sigma methodologies)
• Highly automated equipment (inspection, packaging, filling, assembly, etc.)
• SAP, Master Control or other QMS, Electronic Batch Records

Other Job Details

Work Location: On Premises, Full Time

Sunshine Act

Pherros Biosciences reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pherros to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pherros intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pherros that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pherros Biosciences is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pherros Biosciences also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Manufacturing Science

Pherros Biosciences careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We are looking for new talent to join our global community in order to unearth new innovative therapies that make the world a healthier place.

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