Manufacturing Associate jobs at Takeda Pharmaceuticals U.S.A., Inc. - 314 jobs

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Manufacturing Associate II is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment. Performs various semi-routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management. Assists in the research and implementation of new methods and technologies to enhance operations. Prepares components, media, buffers, and other solutions as needed. Accurately documents data and writes/reviews batch records under cGMP guidelines. Prepares material components for production. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: High school diploma required. Bachelors in a science or engineering discipline preferred. Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions. Ability to work with cross functional teams. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Demonstrated ability to follow detailed directions in a manufacturing GMP environment. Familiarity with cGMP, manufacturing, machine operations, and data entry. Must be familiar with Microsoft Office applications. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties the employee is: constantly perform duties while donning aseptic gowning. constantly required to sit, and to reach to use computers and other office equipment constantly stand for extended periods of time, up to four (4) hours/time. frequently required to lift up to 50 pounds constantly required to view objects at close and distant ranges with hand and eye coordination frequently required to communicate with others Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. *The hiring rate for this position is $27.09 -$31.60 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-KC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ:For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: **********************************

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Drug Product Manufacturing Associate II Location: Lusk and Roselle The Manufacturing Associate II is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment. Performs various semi-routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management. Assists in the research and implementation of new methods and technologies to enhance operations. Prepares components, media, buffers, and other solutions as needed. Accurately documents data and writes/reviews batch records under cGMP guidelines. Prepares material components for production. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture. Schedule: 2nd Shift: Starts at 2:00pm Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: High school diploma required. Bachelors in a science or engineering discipline preferred. Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions. Ability to work with cross functional teams. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Demonstrated ability to follow detailed directions in a manufacturing GMP environment. Familiarity with cGMP, manufacturing, machine operations, and data entry. Must be familiar with Microsoft Office applications. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties the employee is: constantly perform duties while donning aseptic gowning. constantly required to sit, and to reach to use computers and other office equipment constantly stand for extended periods of time, up to four (4) hours/time. frequently required to lift up to 50 pounds constantly required to view objects at close and distant ranges with hand and eye coordination frequently required to communicate with others Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. *The hiring rate for this position is $27.09-$31.60 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-KC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ:For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: **********************************

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Manufacturing Associate II is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. + Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. + Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment. + Performs various semi-routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. + Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management. + Assists in the research and implementation of new methods and technologies to enhance operations. + Prepares components, media, buffers, and other solutions as needed. + Accurately documents data and writes/reviews batch records under cGMP guidelines. + Prepares material components for production. + Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. + Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. + Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **Required:** + High school diploma required. Bachelors in a science or engineering discipline preferred. + Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions. + Ability to work with cross functional teams. + Detail oriented with strong written and verbal communication skills. + Ability to work independently, within prescribed guidelines, or as a team member. + Demonstrated ability to follow detailed directions in a manufacturing GMP environment. + Familiarity with cGMP, manufacturing, machine operations, and data entry. + Must be familiar with Microsoft Office applications. **Physical Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties the employee is: + constantly perform duties while donning aseptic gowning. + constantly required to sit, and to reach to use computers and other office equipment + constantly stand for extended periods of time, up to four (4) hours/time. + frequently required to lift up to 50 pounds + constantly required to view objects at close and distant ranges with hand and eye coordination + frequently required to communicate with others Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. ***** The hiring rate for this position is $27.09 -$31.60 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. \#LI-KC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ: For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: ********************************** Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Drug Product Manufacturing Associate II Location: Lusk and Roselle The Manufacturing Associate II is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. + Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. + Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment. + Performs various semi-routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. + Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management. + Assists in the research and implementation of new methods and technologies to enhance operations. + Prepares components, media, buffers, and other solutions as needed. + Accurately documents data and writes/reviews batch records under cGMP guidelines. + Prepares material components for production. + Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. + Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. + Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture. **Schedule:** 2nd Shift: Starts at 2:00pm **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **Required:** + High school diploma required. Bachelors in a science or engineering discipline preferred. + Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions. + Ability to work with cross functional teams. + Detail oriented with strong written and verbal communication skills. + Ability to work independently, within prescribed guidelines, or as a team member. + Demonstrated ability to follow detailed directions in a manufacturing GMP environment. + Familiarity with cGMP, manufacturing, machine operations, and data entry. + Must be familiar with Microsoft Office applications. **Physical Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties the employee is: + constantly perform duties while donning aseptic gowning. + constantly required to sit, and to reach to use computers and other office equipment + constantly stand for extended periods of time, up to four (4) hours/time. + frequently required to lift up to 50 pounds + constantly required to view objects at close and distant ranges with hand and eye coordination + frequently required to communicate with others Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. ***** The hiring rate for this position is $27.09 -$31.60 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. \#LI-KC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ: For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: ********************************** Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Manufacturing Associate I is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. Train in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. Train on required SOP's and execute training curriculum. Prepare materials needed for aseptic operations. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Performs various routine manufacturing tasks on complex equipment under the guidelines of established SOP's and cGMP regulations. Accurately documents data and completes batch records as needed. Reliably executes well defined SOP's. Operates in clean room environments in accordance with established policies and procedures. Collects and disposes of lab wastes according to established procedures. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: High school diploma required. Bachelors in a science or engineering discipline preferred. Minimum of zero to two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions. Ability to follow instructions with direct supervision. Detail oriented with strong written and verbal communication skills. Demonstrated ability to follow detailed directions in a manufacturing GMP environment. Familiarity with cGMP, manufacturing, machine operations, and data entry. Must be familiar with Microsoft Office applications. Physical Demands: While performing the duties the employee is: occasionally required to sit, and to reach to use computers and other office equipment occasionally stand for extended periods of time, up to four (4) hours/time occasionally required to lift up to 40 pounds constantly required to view objects at close and distant ranges frequently required to communicate with others Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. *The hiring rate for this position is $21.98 -$25.64 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-KC1 #SD1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ:For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: **********************************

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Sterile Manufacturing Associate The Sterile Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen. The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures. Responsibilities: Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection. Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions. Comply with all gowning requirements and environmental control procedures to maintain sterile conditions. Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols. Support execution of media fills, process validations, and cleanroom qualification activities. Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies. Complete all training in a timely manner and maintain qualification for aseptic operations. Accurately record all activities in cGMP documentation, ensuring data integrity. Assist with investigations, deviations, CAPAs, and continuous improvement initiatives. Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs. Follow safety, health, and environmental policies and procedures. Qualifications: Education/Experience: High School diploma or GED required; Associate's or Bachelor's degree in Life Sciences or related field preferred. Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred. Experience in cGMP-regulated environments is highly desirable. Knowledge, Skills, and Abilities: Strong understanding of aseptic technique, cleanroom behavior, and contamination control. Ability to read and follow SOPs, batch records, and manufacturing instructions precisely. Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods. Detail-oriented with strong documentation and communication skills. Ability to work independently and as part of a collaborative team. Willingness to work flexible shifts and weekends as required by production schedule. Requirements: Valid driver's license and acceptable driving record. Legally authorized to be employed in the United States. This role is an onsite role and requires daily commuting to and from the facility. This role requires work in a controlled cleanroom environment with strict gowning and hygiene protocols. Must be able to stand for extended periods, lift up to 50 pounds, and perform repetitive tasks. Benefits: Fulltime Employment $28 - $32 per hour (Based on Experience) Annual Bonus eligibility Medical, Dental and Vision coverage PTO plan 401K plan Additional Information: Nivagen Pharmaceuticals affords equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Sterile Manufacturing Associate The Sterile Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen. The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures. Responsibilities: Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection. Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions. Comply with all gowning requirements and environmental control procedures to maintain sterile conditions. Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols. Support execution of media fills, process validations, and cleanroom qualification activities. Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies. Complete all training in a timely manner and maintain qualification for aseptic operations. Accurately record all activities in cGMP documentation, ensuring data integrity. Assist with investigations, deviations, CAPAs, and continuous improvement initiatives. Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs. Follow safety, health, and environmental policies and procedures. Qualifications: Education/Experience: High School diploma or GED required; Associate's or Bachelor's degree in Life Sciences or related field preferred. Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred. Experience in cGMP-regulated environments is highly desirable. Knowledge, Skills, and Abilities: Strong understanding of aseptic technique, cleanroom behavior, and contamination control. Ability to read and follow SOPs, batch records, and manufacturing instructions precisely. Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods. Detail-oriented with strong documentation and communication skills. Ability to work independently and as part of a collaborative team. Willingness to work flexible shifts and weekends as required by production schedule. Requirements: Valid driver's license and acceptable driving record. Legally authorized to be employed in the United States. This role is an onsite role and requires daily commuting to and from the facility. This role requires work in a controlled cleanroom environment with strict gowning and hygiene protocols. Must be able to stand for extended periods, lift up to 50 pounds, and perform repetitive tasks. Benefits: Fulltime Employment $28 - $32 per hour (Based on Experience) Annual Bonus eligibility Medical, Dental and Vision coverage PTO plan 401K plan Additional Information: Nivagen Pharmaceuticals affords equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact. Your Role: 3rd Shift Position - 10 PM to 6:30 AM Sunday night to Friday morning This position requires knowledge and ability to perform duties related to the manufacturing of drug products in a cleanroom environment, aseptic, device and assembled products utilizing reliable methods according to established procedures. Your Profile: Responsibilities Completes training modules regarding cleaning and sanitization methods for aseptic environments, this includes but is not limited to the use of germicidal/bactericidal/veridical/ agents, isopropyl alcohol, Sporklenz, Minnteck etc. Completes training modules regarding gowning techniques for the entrance to and from ISO 5/6 designated areas. Performs set up activities and operates aseptic filling machines. Perform cleaning activities post fill. Ability to assess the process performed, and if necessary, stop a line to insure a quality product. Ensures good document practices in the recording, maintenance, reviewing and organizing of batch records, forms, documents and logbooks for responsible areas. Assists other team members in manufacturing areas when needed. Maintain good work place organization and housekeeping. Responsible for adhering to applicable SOP, GMP and ISO rules and regulations related to the position. Train and instruct personnel to perform tasks following appropriate SOPs. Any and all other related duties as assigned by immediate supervisor. Required Knowledge, Skills and Abilities Good oral and written communication skills Good team and problem solving skills Initiative and manual dexterity Ability to stand continuously for two or more hours while wearing proper gowning materials Ability to work safely and use all material moving equipment in a safe manner Basic math skills Ability to work overtime as necessary Required Education and Experience High school graduate or equivalent A minimum of 4+ years of aseptic filling operator experience Pharmaceutical industry experience helpful Experience with cGMP and aseptic gowning for ISO 5/6 helpful Target Pay Range: $27-30/hour + 15% Differential when working on 3rd Shift Your Benefits: Medical, Dental Vision Life, Accident, Disability Voluntary Life, AD&D, Pet 401K Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our: focus on science and innovation, we aim to offer a lifetime of clearer vision commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases. We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This person will report directly to the Manufacturing Manager within the manufacturing group to perform specific production builds in our GMP cleanroom environment. This position requires someone to have excellent hand/eye coordination as they will be working with our extremely small products. This position is located at our Northbridge, MA site. This role will require an eye exam. Excellent Compensation Package, including Equity and Comprehensive Benefits upon hire. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual responsibilities Execute necessary builds adhering to governmental guidelines, good manufacturing practices (GMP's) and company procedures. Schedule and plan daily manufacturing builds & duties in a team environment. Ensure that work environment is maintained clean, safe and organized. Maintain and complete manufacturing documents and quality records for manufacturing products. Maintain the accuracy and movement of raw materials used in manufacturing, including job kitting and cycle counting. Maintain daily cleaning activities and logs for manufacturing areas and equipment. Analyze root causes of production issues and develop corrective actions. Guide other Associates in their assigned duties when needed. Work with all departments at EyePoint. Other tasks as assigned. Primary responsibilities include, but are not limited to, the following: Individual responsibilities Execute necessary builds adhering to governmental guidelines, good manufacturing practices (GMP's) and company procedures. Schedule and plan daily manufacturing builds & duties in a team environment. Ensure that work environment is maintained clean, safe and organized. Maintain and complete manufacturing documents and quality records for manufacturing products. Maintain the accuracy and movement of raw materials used in manufacturing, including job kitting and cycle counting. Maintain daily cleaning activities and logs for manufacturing areas and equipment. Analyze root causes of production issues and develop corrective actions. Guide other Associates in their assigned duties when needed. Work with all departments at EyePoint. Other tasks as assigned. Qualifications Primary skills and knowledge required include, but are not limited to the following: Manufacturing and Laboratory Safety experience Previous experience working with medical device and microscope assembly work. Previous experience using semi-automated systems would be a plus. Level of Education Required: High School Diploma or equivalent Number of Years of Experience in the Function and in the Industry: Two plus years of experience working in a GMP environment preferably in the pharmaceutical/biopharmaceutical or medical device industry, but not required. Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. This position is classified as non-exempt and is eligible for overtime pay in accordance with federal and state wage and hour laws. The target salary range for this position is listed below. #LI-Onsite Primary skills and knowledge required include, but are not limited to the following: Manufacturing and Laboratory Safety experience Previous experience working with medical device and microscope assembly work. Previous experience using semi-automated systems would be a plus. Level of Education Required: High School Diploma or equivalent Number of Years of Experience in the Function and in the Industry: Two plus years of experience working in a GMP environment preferably in the pharmaceutical/biopharmaceutical or medical device industry, but not required. Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. This position is classified as non-exempt and is eligible for overtime pay in accordance with federal and state wage and hour laws. The target salary range for this position is listed below. #LI-Onsite Min USD $69,010.00/Yr. Max USD $86,863.00/Yr.

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact. Your Role: The Component Prep role is on 1st Shift (6 AM - 2:30 PM) This position requires knowledge and ability to perform duties related to the manufacturing of drug, aseptic, device and assembled products utilizing reliable methods according to established procedures. Your Profile: Responsibilities Completes training modules regarding cleaning and sanitization methods for aseptic environments, this includes but is not limited to the use of germicidal/bactericidal/veridical/ agents, isopropyl alcohol, Sporklenz, Minnteck etc. Completes training modules regarding gowning techniques for the entrance to and from ISO designated areas. Ensures the proper use of filter integrity testers. Surface sanitize/ sterilize equipment, supplies and tools required for Classified Area usage. Ensure equipment inventory is accurate and appropriated marked. Prepare equipment and components for autoclaving. Prepare tubing set assembly per drawings and procedures. Ensures good document practices in the recording, maintenance, reviewing and organizing of batch records, forms, documents and logbooks for responsible areas. Assists other team members in manufacturing areas when needed. Maintain good work place organization and housekeeping. Responsible for adhering to applicable SOP, GMP and ISO rules and regulations related to the position. Train and instruct personnel to perform tasks following appropriate SOPs. Any and all other related duties as assigned by immediate supervisor. Required Knowledge, Skills and Abilities Good oral and written communication skills Good team and problem solving skills Initiative and manual dexterity Ability to stand continuously for two or more hours while wearing proper gowning materials Ability to work safely and use all material moving equipment in a safe manner Basic math skills Ability to work overtime as necessary Required Education and Experience High school graduate or equivalent A minimum of 1 to 2 years of industry experience Pharmaceutical industry experience helpful Experience with cGMP environment helpful Target Pay Range: $23.50 - 25.50/hour Your Benefits: Medical, Dental, Vision, Life Voluntary Accident, Critical Illness, Hospital, Pet FSA, HSA 401K Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Associate Director, Cell & Gene Therapies External Manufacturing Operations - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (based in US, New England) The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CMO's site and/or be able to travel up to 50% of their time to those sites as a "Person-in-Plant" to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. Key Responsibilities: * Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs) * Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management); be Vertex's "eyes and ears" at the CMO for right-first-time execution of commercial operations. * Proactively "connect the dots" on emerging trends and issues and lead/influence cross functional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply * Maintain on-site presence at CMO facilities for extended periods (including off hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections. * Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. * Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g. issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget). * Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing. * Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization. * Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements. * Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality leadership. * Collaborate with CMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments. * Lead continuous improvement initiatives to affect timely resolution of supply issues. * Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders. Minimum Requirements: * Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry. * Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations. * Strong technical background in aseptic manufacturing operations. * Solid project management skills and experience managing complex projects. * Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience. * Strong leadership and an innate ability to collaborate and build relationships is critical. * Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change * Flexibility to work shift hours required to cover critical process steps * Ability to travel, national and international, up to 50% * Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems Desired Additional Skills: * Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. * Solid experience in equipment and facility qualification and validation for ATMP CMO's * Cleanroom qualification (Grade A/B) history Environment: * Office and cleanroom - must be able to comply with cleanroom gowning requirements at CMO * Must be able to remain in a stationary position 50% during cleanroom processing activities * Must be comfortable moving about inside the cleanroom to oversee process tasks * Compressed gasses and LN2 are commonly used in manufacturing operations * Human tissue (e.g. apheresis) and cellular materials are commonly used Pay Range: $160,000 - $240,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Associate Director, Cell & Gene Therapies External Manufacturing Operations - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (based in US, New England) The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CMO's site and/or be able to travel up to 50% of their time to those sites as a “Person-in-Plant” to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. Key Responsibilities: Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs) Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management); be Vertex's “eyes and ears” at the CMO for right-first-time execution of commercial operations. Proactively “connect the dots” on emerging trends and issues and lead/influence cross functional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply Maintain on-site presence at CMO facilities for extended periods (including off hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections. Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g. issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget). Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing. Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization. Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements. Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality leadership. Collaborate with CMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments. Lead continuous improvement initiatives to affect timely resolution of supply issues. Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders. Minimum Requirements: Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry. Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations. Strong technical background in aseptic manufacturing operations. Solid project management skills and experience managing complex projects. Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience. Strong leadership and an innate ability to collaborate and build relationships is critical. Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change Flexibility to work shift hours required to cover critical process steps Ability to travel, national and international, up to 50% Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems Desired Additional Skills: Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. Solid experience in equipment and facility qualification and validation for ATMP CMO's Cleanroom qualification (Grade A/B) history Environment: Office and cleanroom - must be able to comply with cleanroom gowning requirements at CMO Must be able to remain in a stationary position 50% during cleanroom processing activities Must be comfortable moving about inside the cleanroom to oversee process tasks Compressed gasses and LN2 are commonly used in manufacturing operations Human tissue (e.g. apheresis) and cellular materials are commonly used Pay Range: $160,000 - $240,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Manufacturing Associate is for the night shift from 7 PM - 7 AM, on a rotational schedule every other week: Week 1: Mon, Tues, Fri, Saturday Week 2: Sun, Wed, Thursday Shift differentials are included for nights and weekends worked Initial 2-week training period may be day shift hours Mon-Fri The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level III associates are expected to be fully proficient in executing process recipes, following written procedures (SOPs), monitoring equipment and processes, independently performing laboratory tasks, including pH, conductivity testing, product sampling, and conducting routine sanitization tasks to maintain facility and equipment and train other operators on these tasks. They are expected to demonstrate a significant knowledge of cGMP compliance and an in-depth understanding of process flow and be able to make decisions based on that experience. Experienced Level II & III Operators are able to troubleshoot routine and non-routine equipment events, initiate deviations, review batch records and logbooks. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. And much more! Our full list of global benefits can be found here: *************************************** What you will do: Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate. Demonstrate proficiency and understanding of suite specific production activities and laboratory tasks such as bioreactor inoculation, chromatography column operation, product sampling, etc. and the scientific theory behind the operations. May train other associates on these tasks and theory. Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects, technical writing (deviations, document change forms, etc.). Attain qualification for all assigned tasks and maintain individual training plan. Perform material movements, transfer raw materials, chemicals into, out of, across the production areas. Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Perform other duties as assigned. What we are looking for: High School Diploma or equivalent. Bachelor's Degree preferred. 2+ years GMP manufacturing experience preferred. Ability to wear appropriate PPE required. Proven logic and decision-making abilities, critical thinking skills. Strong written and verbal communication skills required. About Lonza: At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Follows the lead of the Packaging Specialists during the packaging of a batch and during the closing of a batch. Inspects the finished product before placing the finished product into a carton. Checks the quality of the finished product by performing in process checks and documenting findings in batch record. Notifies Quality and Production Supervisors if the product fails the required specifications. Responsibilities: * Maintains a cGMP area. * Follows all required SOPs and work instructions and safety procedures. * Documents all required information to ensure compliance. * Performs in process checks efficiently. * Supports packaging operators during the opening and closing of a batch. * Places finished product into cartons and seals. * Supports engineering studies. * Supports weekly and monthly cleans. * Follows all DEA requirements to ensure compliance to regulations. * Other projects and duties as assigned. Qualifications: * High School Diploma or GED required; college degree desired for future opportunities within Aquestive. * Possess basic mathematical skills: addition, subtraction, multiplication and division. * Ability to communicate effectively both orally and written. * Desire to work in fast paced, heavily regulated environment that requires significant attention to detail; high degree of accuracy and utmost integrity to ensure the safety and efficacy of our products. * Willingness to work various shifts in a 24/7 operation. * Strong attention to detail to ensure effective inspection. * Willingness to be proactive; comfortable in raising concerns regarding inspection results. * Ability to take specific direction, with no room for error. * Ability to work in a team environment, and collaborate effectively across teams, functions and shifts. * Ability to lift up to 30 pounds. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Follows the lead of the Packaging Specialists during the packaging of a batch and during the closing of a batch. Inspects the finished product before placing the finished product into a carton. Checks the quality of the finished product by performing in process checks and documenting findings in batch record. Notifies Quality and Production Supervisors if the product fails the required specifications. Responsibilities: Maintains a cGMP area. Follows all required SOPs and work instructions and safety procedures. Documents all required information to ensure compliance. Performs in process checks efficiently. Supports packaging operators during the opening and closing of a batch. Places finished product into cartons and seals. Supports engineering studies. Supports weekly and monthly cleans. Follows all DEA requirements to ensure compliance to regulations. Other projects and duties as assigned. Qualifications: High School Diploma or GED required; college degree desired for future opportunities within Aquestive. Possess basic mathematical skills: addition, subtraction, multiplication and division. Ability to communicate effectively both orally and written. Desire to work in fast paced, heavily regulated environment that requires significant attention to detail; high degree of accuracy and utmost integrity to ensure the safety and efficacy of our products. Willingness to work various shifts in a 24/7 operation. Strong attention to detail to ensure effective inspection. Willingness to be proactive; comfortable in raising concerns regarding inspection results. Ability to take specific direction, with no room for error. Ability to work in a team environment, and collaborate effectively across teams, functions and shifts. Ability to lift up to 30 pounds. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

The Manufacturing Associate plays a key role in assisting in all activities associated with the manufacturing of products and to ensure production assignments are met in a timely manner. Reports to: Manufacturing Supervisor Location: Johnson City TN Schedule: 4x12 Weekday Nights Hours: Monday-Thursday 6PM-6AM Responsibilities/Essential Duties: Assist Manufacturing Supervisor in the day to day operations of the manufacturing department. Assist in mixing all chemicals needed for products using a recipe determined by Crown Laboratories documenting each batch used. Assist in all activities associated with the production of products in accordance with the issued batch record. Assist in keeping journal logbooks up to date Assure all utensils are cleaned and washed after using. Keep area neat and orderly. Keep production process flowing smoothly, helping as needed on production line. Inventory all chemicals and raw materials in manufacturing area at the end of every month or as needed for Inventory Control. Assist in other departments or areas as needed. Conform to all cGMP procedures and Standard Operating Procedures. Basic Qualifications: Three to five years experience in a manufacturing facility. Some knowledge of metric system. Punctual and consistent attendance. High school diploma or equivalent Consistent and punctual attendance. Must be quality driven with good attention to detail but also be able to work in a fast-paced environment. Working Conditions/Physical Requirements Must be able to lift approximately 80-100 lbs. Must be able to stand for long periods of time. Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus Paid time off, holidays, and floating holidays that can be used for whatever you choose Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

**Why Us?** At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. ** Summary** Processes active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. **Job Description** **Raw Materials and Equipment Checklist Successfully Completed** Obtain and weigh in products for all shifts Moves raw materials and product to/from vault, cage, process or storage areas. Inspects machine parts for unusual wear and proper lubrication. Operates equipment required in the manufacture of pharmaceutical product. Performs/reviews quality checks on weight, thickness, hardness and friability of tablets at various stages of the process according to manufacturing instructions and SOPs. Submits product samples to quality laboratories as required. Maintains product batch, room activity, and equipment records. Maintains control of DEA scheduled material in accordance with accepted policy, practice and procedure. **Work Center Schedule and Shift Attainment Achieved to Standards** Is at his/her position on the line ready to start production as required. Monitors the production process, makes periodic checks and adjusts equipment or work practices to maximize production efficiency, yields, quality and safety. Accurately reports production and ensures reports are completed as required. Performs operator-level machine adjustments and lubrication. Assists technicians with minor machine repairs and set-up. Troubleshoots problems with equipment and processing to assist other technicians to minimize disruptions to production. Ensures that line conditions are acceptable to change from one product to another by ensuring that materials, paperwork, and equipment have been staged for changeover. **Downtime Avoided** Will immediately stop manufacturing and notify Line Leader of any safety or quality concerns. Documents inspections performed and keeps accurate equipment records, clean-up sheets and other required paperwork. Disassembles, cleans and reassembles basic line equipment according to SOPs. Insures proper inspections are conducted prior to reassembly. Cleans and assembles dust collector. Assists in the training of individuals on equipment and processes in the department. **Compliance Standards Met** Follows all EHS rules and regulations. Accepts accountability for own personal safety and identifies potential unsafe conditions to help prevent self and co-workers from being injured. Complies with all site security requirements. Performs lock-out/tag-out procedures according to SOPs. Follows safe working practices in the execution of their assigned duties. Collects all process related hazardous wastes and transports to accumulation drums. Actively participates in general site and departmental Safety initiatives. Maintains clean work area; clear away debris, damaged or defective product, cartons, labels and packaging supplies. **Escalation Process Adhered to** Makes initial attempts to identify root cause within scope of decision-making authority while simultaneously notifying next level of leadership. If attempts at the next level do not resolve the problem and the Associate believes that a higher level needs to be involved, the problem is escalated to the highest level. **Marginal Functions** Assists technicians at other stations within the department as needed. Works on any tableting stations on which you are trained May be crossed-trained in other functions Minimum Requirements **_Education:_** Requires the basic knowledge and ability to apply mathematical concepts, spelling, reading English, and grammar. Requires a High School diploma or GED. **_Experience:_** Recommended minimum of three to twelve months' experience under direct supervision and guidance in order to gain sufficient skill to perform the requirements of the position. **Working Conditions:** Location: Hobart, NY Facility Hours: Monday - Thursday 8:00pm to 6:15am Must have the ability to work overtime when needed. **Pay Transparency:** The expected base pay for this position is $23.44 per hour plus a $3.00 shift differential. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion. This position is not eligible for visa sponsorship. Applicants must be authorized to work in the United States without current or future sponsorship needs. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary Processes active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. Job Description Raw Materials and Equipment Checklist Successfully Completed Obtain and weigh in products for all shifts Moves raw materials and product to/from vault, cage, process or storage areas. Inspects machine parts for unusual wear and proper lubrication. Operates equipment required in the manufacture of pharmaceutical product. Performs/reviews quality checks on weight, thickness, hardness and friability of tablets at various stages of the process according to manufacturing instructions and SOPs. Submits product samples to quality laboratories as required. Maintains product batch, room activity, and equipment records. Maintains control of DEA scheduled material in accordance with accepted policy, practice and procedure. Work Center Schedule and Shift Attainment Achieved to Standards Is at his/her position on the line ready to start production as required. Monitors the production process, makes periodic checks and adjusts equipment or work practices to maximize production efficiency, yields, quality and safety. Accurately reports production and ensures reports are completed as required. Performs operator-level machine adjustments and lubrication. Assists technicians with minor machine repairs and set-up. Troubleshoots problems with equipment and processing to assist other technicians to minimize disruptions to production. Ensures that line conditions are acceptable to change from one product to another by ensuring that materials, paperwork, and equipment have been staged for changeover. Downtime Avoided Will immediately stop manufacturing and notify Line Leader of any safety or quality concerns. Documents inspections performed and keeps accurate equipment records, clean-up sheets and other required paperwork. Disassembles, cleans and reassembles basic line equipment according to SOPs. Insures proper inspections are conducted prior to reassembly. Cleans and assembles dust collector. Assists in the training of individuals on equipment and processes in the department. Compliance Standards Met Follows all EHS rules and regulations. Accepts accountability for own personal safety and identifies potential unsafe conditions to help prevent self and co-workers from being injured. Complies with all site security requirements. Performs lock-out/tag-out procedures according to SOPs. Follows safe working practices in the execution of their assigned duties. Collects all process related hazardous wastes and transports to accumulation drums. Actively participates in general site and departmental Safety initiatives. Maintains clean work area; clear away debris, damaged or defective product, cartons, labels and packaging supplies. Escalation Process Adhered to Makes initial attempts to identify root cause within scope of decision-making authority while simultaneously notifying next level of leadership. If attempts at the next level do not resolve the problem and the Associate believes that a higher level needs to be involved, the problem is escalated to the highest level. Marginal Functions Assists technicians at other stations within the department as needed. Works on any tableting stations on which you are trained May be crossed-trained in other functions Minimum Requirements Education: Requires the basic knowledge and ability to apply mathematical concepts, spelling, reading English, and grammar. Requires a High School diploma or GED. Experience: Recommended minimum of three to twelve months' experience under direct supervision and guidance in order to gain sufficient skill to perform the requirements of the position. License(s)/Certification(s) required: None Required Working Conditions: Physical/Visual Activities or Demands: Physical/visual activities or demands that are commonly associated with the performance of the functions of this job. 1. Heavy physical demand requires frequent moving, pushing, pulling, rolling and dumping of up to 100 kg and manual lifting of up to 25 kg. Physical demand also involves walking and standing (70%), balancing, bending, kneeling and reaching (15%), grasping and feeling (5%) and communicating (10%). 2. Mental demand is frequent requiring attention to details of specific manufacturing instructions and recording of information on paperwork. 3. Visual demand is continuous and requires clarity of vision at 20 inches or less and 20 feet or more with peripheral vision and the ability to bring objects into sharp focus, to judge distance and space relationships and to identify and distinguish colors. Environmental/Atmospheric Conditions: Environmental and atmospheric conditions commonly associated with the performance of the functions of this job. 1. Exposure to pure raw materials requires incumbent to wear a respirator on a regular basis. 2. Protective clothing and equipment including uniform shirt and slacks, jacket, safety glasses, booties, hairnet, gloves, disposable respirator, hearing protection, PAPR, and tyvek suit are worn continuously in the performance of the job functions. 3. Exposure to noise requires incumbent to wear hearing protection on regular basis. 4. Work hazards include proximity to moving mechanical parts, exposure to dust, odors, cleaning agents, noise, and vibration. Working Conditions: Location: Hobart, NY Facility Hours: Monday - Thursday 4:00pm to 2:15am Must have the ability to work overtime when needed. Pay Transparency: The expected base pay for this position is $23.44 per hour plus a $2.00 shift differential. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion. This position is not eligible for visa sponsorship. Applicants must be authorized to work in the United States without current or future sponsorship needs. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Manufacturing Associate III The shift schedule is from 7am-7pm, on a rotational schedule every other week: Week 1: Sun, Wed, Thurs Week 2: Mon, Tues, Fri, Sat Shift differentials are included for weekends worked The Manufacturing Associate III is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level III associates are expected to be fully proficient in executing process recipes, following written procedures (SOPs), monitoring equipment and processes, independently performing laboratory tasks, including pH, conductivity testing, product sampling, and conducting routine sanitization tasks to maintain facility and equipment and train other operators on these tasks. They are expected to demonstrate a significant knowledge of cGMP compliance and an in-depth understanding of process flow and be able to make decisions based on that experience. Level III Operators are able to troubleshoot routine and non-routine equipment events, initiate deviations, review batch records and logbooks. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. Our full list of global benefits can be found here: *************************************** What you will do: Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate. Demonstrate proficiency and understanding of suite-specific production activities and laboratory tasks such as bioreactor inoculation, chromatography column operation, product sampling, etc. and the scientific theory behind the operations. May train other associates on these tasks and theory. Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects, technical writing (deviations, document change forms, etc.). Attain qualification for all assigned tasks and maintain individual training plan Perform material movements, transfer raw materials, chemicals into, out of, across the production areas. Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Perform other duties as assigned. What we are looking for: High School Diploma or equivalent. Bachelor's Degree preferred 2+ years GMP manufacturing experience preferred. Ability to wear appropriate PPE required Able to follow written procedures Proven logic and decision-making abilities, critical thinking skills Strong written and verbal communication skills required Able to navigate deadlines and a quickly changing environment About Lonza: At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.