Descripción de funciones
The Staff Process Specialist - Manufacturing position provides on the floor direction on the manufacturing process. Key member in the implementation of the manufacturing production program.
As a Staff Process Specialist - Manufacturing, a typical day might include the following:
- Provides technical input to resolve process problems both on and off the production suites
- Coaches manufacturing personnel to increase technical knowledge of critical process steps on the floor.
- Supports Manufacturing personnel on implementing improvements to the process or work systems in the suites.
- Supports CAPA implementation on process related improvements.
- Supports onsite educational programs to enhance technical competence of manufacturing personnel.
- Supports all aspects of the manufacturing process according to approved protocols, regulation, and schedule
- Supports the technology transfer of the manufacturing process
- Liaises with the process science/technology transfer teams in relation to the transfer and startup of the manufacturing process.
- Prepares reports by collecting, analyzing, and summarizing information and trends. Operations member reviewing trends with the Process Science Group. Present out on process trends.
- Leads investigations into process variances according to site procedures.
- Ensures that policies and procedures are effectively administered and that they comply with regulatory requirements.
- Communicates well with supervisors on major problems regarding the process, schedules and materials.
- Guides and oversees validation activities involving manufacturing equipment and processes.
- Interfaces with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
- Works to the highest safety standards. Supports safety improvements which require technical/engineering input.
- Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
- Performs cGMP audits of production area.
- Represents manufacturing during regulatory and client audits. Will also respond to some of the findings from these audits.
- Writes, reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
- Leads and implements continuous improvement initiatives.
- Will act as system owner for defined manufacturing equipment and will be involved in the scheduling of all non-routine activities for that equipment.
This role may be for you if:
- Knowledge of cGMP manufacturing environment and familiarity with formulation, aseptic filling, visual inspection (manual and automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products.
- Demonstrated strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.
- Exhibits confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness.
- Ability to gain understanding from provided instructions and work towards established goals individually or as part of a team.
- Ability to understand and listen to team members and stakeholders’ needs while supporting a positive team environment
- Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred.
- Previous experience providing technical support preferred.
- Experience with lyophilization is a plus.
- Experience with operating and qualifying equipment with high levels of automation is a plus.
In order to be considered for this position, you must hold a BS in Life Sciences or related field and
- Principal Process Specialist - 8 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry or equivalent combination of education and experience.
- Staff Process Specialist - 10 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry.
- Senior Staff Process Specialist - 12 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry.
- May consider experience in lieu of education OR equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)