Production Supervisor
Columbus, OH jobs
We're hiring a Production Supervisor to lead packaging operations for an established manufacturer in South Columbus, OH area.
What You'll Do:
Oversee daily production operations and maintain workflow efficiency
Manage inventory levels and coordinate with purchasing and logistics teams
Supervise production team members (direct reports plus agency staff as needed)
Ensure compliance with cGMP, FDA, and Department of Agriculture regulations
Maintain accurate documentation for regulatory requirements
Analyze production data and metrics to identify improvement opportunities
Partner with Quality Assurance and Technical Operations on equipment performance
Conduct staff reviews, manage performance, and train team members
Generate reports and communicate production updates to leadership
Implement safety protocols and maintain clean, safe work environment
What We're Looking For:
Bachelor's degree or equivalent experience managing manufacturing operations
Background in pharmaceutical, nutraceutical, or regulated production environments strongly preferred
Solid understanding of cGMP and regulatory compliance requirements
CPIM certification a plus
Strong analytical and problem-solving abilities
Excellent communication skills (verbal and written) for cross-functional collaboration
Proficiency in MS Excel, Word, Outlook, and inventory management systems
Experience with timekeeping software (ADP or similar)
Ability to lift 40 lbs regularly and stand/walk for extended periods
Strong organizational and time-management skills
What We Offer:
Direct hire opportunity
Competitive salary: $70,000-$74,000
Reports to Director of Operations
Hands-on leadership role in stable manufacturing environment
Minimal travel - operations-focused position
Opportunity for expanded responsibilities
Apply now: Submit your resume for review.
Operations Lead
Lakewood, NJ jobs
YOUR PASSION, ACTIONS & FOCUS is our Strength.
Become one of our Contributors!
Join the KnipperHEALTH Team!
works 7:30 - 4:00pm
The Operations Lead will focus on the safety, quality and productivity of associates engaged in Operations activities assigned to them The Operations Lead will ensure that equipment is utilized as intended by the manufacturer with all guards and safety devices in place. The Operations Lead will ensure compliance with all applicable regulations, best practices, and Standard Operating Procedures (e.g. line clearance, inventory reconciliation, current Good Manufacturing Practices (cGMP), and OSHA.) The Operations Lead is directly responsible for meeting promise-by times and the productivity of the line and associates under their supervision.
This position works the hours of Monday-Friday 7:30 am ET - 4:00pm ET
Responsibilities
KEY RESPONSIBILITIES:
Maintain a safe Operations environment.
Ensure compliance with applicable regulations (including line clearance, product reconciliation, and sanitation) procedures, and industry best practices.
Deploy labor, equipment, and systems focused on achieving benchmarks and productivity requirements for assigned job(s).
Accurately report the consumption of resources (e.g., labor, materials, inventory, equipment, postage, etc…)
Manage day-to-day Operations to focus on maintenance and enhancement of the accuracy of work-in-progress and standing inventories.
Ensure that paperwork and databases are updated as close to real time as possible and contain accurate and up-to-date information.
Ensure that all materials, inventory, and equipment are ready in advance of deploying labor to a work center.
Assign individual tasks to associates; assess quality and productivity of output on an on-going basis, making adjustments to line and labor as necessary.
Provide timely input to status and exception reports to Operations Supervisor so that proper client notification and capacity planning adjustment can be made.
Participate in all training and process improvement initiatives.
Supervisory Management
This position is responsible for following the directions of the Operations Supervisor, Operations Manager and other members of the Knipper Operations Management team.
This position is responsible for reporting back to the Operations Supervisor and Operations Manager on any and all situations that require escalation to management.
The above duties are meant to be representative of the position and not all-inclusive.
Qualifications
MINIMUM JOB REQUIREMENTS:
Education/Training: High School Education or higher.
Business Experience: One year related supervisory experience or training; or equivalent combination of education and experience.
KNOWLEDGE, SKILLS & ABILITIES:
Basic Supervisory Skills or training (including safety and regulatory specific training or experience)
General warehouse or distribution skills
Use of job specific machinery and equipment
Basic to intermediate mathematical skills (counting, adding, multiplying, percentages, calculating line rates, capacities, etc.)
Basic to intermediate computer skills
PHYSICAL DEMANDS:
While performing the duties of this job the employee is:
Frequently required to stand or sit.
Frequently required to stoop, kneel, or crouch.
Frequently required to reach with hands and arms.
Frequently lift and/or move objects up to 20 pounds.
Occasionally lift and/or move objects up to 35 pounds.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Auto-ApplyTransformation Leader - External Manufacturing - Biologics
Cambridge, MA jobs
Job Title: Transformation Leader - External Manufacturing - Biologics About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care.
The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU.
This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU.
This is a hybrid role - 3 days a week onsite - required.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Support Transformation Delivery
* Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU.
* Localize change strategies to fit the GBU context, culture, and priorities.
* Act as a key point of contact for all change-related activities in the GBU.
Drive Adoption & Engagement
* Ensure employees and managers understand the why, what, and how of transformation initiatives.
* Develop and execute communication and training plans to maximize adoption.
* Monitor adoption and embed new behaviors, processes, and tools into the GBU.
Stakeholder & Leadership Support
* Build strong relationships with GBU leaders to support them as change sponsors.
* Provide coaching and guidance to managers and teams to reinforce change behaviors.
* Act as a trusted advisor to GBU leadership on change readiness and risks.
Change Measurement & Reporting
* Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership.
* Identify resistance, barriers, and adoption gaps, and proactively recommend solutions.
* Capture lessons learned to continuously improve change implementation in the GBU.
About You
* Bachelor's degree in Business, Human Resources, Organizational Development, or related field.
* 5+ years of experience in change management or organizational transformation.
* Strong knowledge of CMO/CDMO manufacturing - Required.
* Strong knowledge of change management frameworks
* Demonstrated ability to work in complex, matrixed organizations.
* Excellent communication, facilitation, and interpersonal skills.
* Proven track record in supporting digital, operational, or organizational transformation programs.
* Certification in Change Management or Project Management is a plus.
Key Competencies of a Transformation Leader
As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master:
Vision & Strategy
* Strategic thinking: Ability to see the "big picture" and anticipate trends
* Organizational alignment: Connect transformation to business objectives
Change Management
* Change management: Master methodologies
* Resistance management: Identify and address barriers to change
* Change communication: Adapt messages to different audiences
Operational Competencies
* Project/Program Management
* Business acumen with ability to translate transformation into operational impact.
* Problem-solving and analytical thinking.
* Process optimization: Identify and implement improvements
* Digital literacy: Understand emerging technologies (AI, automation, cloud)
* Innovation: Promote experimentation and learning
Relational Competencies /Leadership & Influence
* Cross-functional work: Orchestrate multi-functional teams
* Inspirational leadership: Mobilize and engage teams
* Influence without authority: Convince stakeholders at all levels and relationship building at GBU level.
* Emotional intelligence: Understand and manage emotions during change change
* Negotiation: Find compromises and create consensus
Soft Skills
* Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling)
* Empathy: Understand the human impact of change
* Resilience and adaptability in dynamic environments.
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$147,000.00 - $212,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Auto-ApplyTransformation Leader - External Manufacturing - Biologics
Cambridge, MA jobs
**Job Title:** Transformation Leader - External Manufacturing - Biologics **About the Job** Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care.
The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU.
This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU.
****This is a hybrid role - 3 days a week onsite - required. ****
**About Sanofi:**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main Responsibilities:**
**Support Transformation Delivery**
+ Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU.
+ Localize change strategies to fit the GBU context, culture, and priorities.
+ Act as a key point of contact for all change-related activities in the GBU.
**Drive Adoption & Engagement**
+ Ensure employees and managers understand the why, what, and how of transformation initiatives.
+ Develop and execute communication and training plans to maximize adoption.
+ Monitor adoption and embed new behaviors, processes, and tools into the GBU.
**Stakeholder & Leadership Support**
+ Build strong relationships with GBU leaders to support them as change sponsors.
+ Provide coaching and guidance to managers and teams to reinforce change behaviors.
+ Act as a trusted advisor to GBU leadership on change readiness and risks.
**Change Measurement & Reporting**
+ Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership.
+ Identify resistance, barriers, and adoption gaps, and proactively recommend solutions.
+ Capture lessons learned to continuously improve change implementation in the GBU.
**About You**
+ Bachelor's degree in Business, Human Resources, Organizational Development, or related field.
+ 5+ years of experience in change management or organizational transformation.
+ Strong knowledge of CMO/CDMO manufacturing - Required.
+ Strong knowledge of change management frameworks
+ Demonstrated ability to work in complex, matrixed organizations.
+ Excellent communication, facilitation, and interpersonal skills.
+ Proven track record in supporting digital, operational, or organizational transformation programs.
+ Certification in Change Management or Project Management is a plus.
**Key Competencies of a Transformation Leader**
As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master:
**Vision & Strategy**
+ Strategic thinking: Ability to see the "big picture" and anticipate trends
+ Organizational alignment: Connect transformation to business objectives
**Change Management**
+ Change management: Master methodologies
+ Resistance management: Identify and address barriers to change
+ Change communication: Adapt messages to different audiences
**Operational Competencies**
+ Project/Program Management
+ Business acumen with ability to translate transformation into operational impact.
+ Problem-solving and analytical thinking.
+ Process optimization: Identify and implement improvements
+ Digital literacy: Understand emerging technologies (AI, automation, cloud)
+ Innovation: Promote experimentation and learning
**Relational Competencies /Leadership & Influence**
+ **Cross-functional work: Orchestrate multi-functional teams**
+ Inspirational leadership: Mobilize and engage teams
+ Influence without authority: Convince stakeholders at all levels and relationship building at GBU level.
+ Emotional intelligence: Understand and manage emotions during change change
+ Negotiation: Find compromises and create consensus
**Soft Skills**
+ **Communication** : Strong communication and facilitation skills (Clarity, active listening, storytelling)
+ **Empathy** : Understand the human impact of change
+ **Resilience** and **adaptability** in dynamic environments.
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
\#GD-SG
\#LI-GZ
\#LI-Onsite
\#vhd
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$147,000.00 - $212,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* .
Global Terms & Conditions and Data Privacy Statement (***************************************************************
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (*****************************
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
Patient Support Center Supervisor
Livingston, NJ jobs
Patient Support Center Supervisor
Department: Patient Support Center / Call Center
Reports To: Director Operations
FLSA: Exempt
The Pharmacies operating hours are 8:00 am - 11:00 pm EST Monday through Friday, and Saturday through Sunday 8:00 am - 8:00 pm EST.
Primary Function:
The incumbent is responsible for executing program requirements and managing daily workflow.
Job Scope and Major Responsibilities:
Managing the workflow of their employees and delegating tasks.
Hold engaging team meetings and/or one-on-ones routinely with Team Leads.
Monitor quality and performance of the team and demonstrate the ability to provide feedback in an effective manner that drives change in behavior and results.
Accomplishes staff job results by coaching, counseling, and disciplining employees.
Training and onboarding.
Work in conjunction with Management Team and the Quality Assurance Team to communicate productivity gaps and quality as it pertains to the program.
Interface with programmers as needed to address any system enhancements or difficulties.
Creating team schedules and time and attendance management.
Setting goals for workers and making sure they comply with the company's policies and procedures.
Identify potential training gaps, escalating these to site leadership.
Alert site leadership to any potential staff matters, including performance or behavioral issues.
Ensuring that business goals, deadlines and performance standards are met
Maintain tracking document and crosscheck to ensure platform/tracking document accuracy
Attend manufacturer meetings to support ongoing program development
Establish effective rapport with other employees, clients, physicians, pharmacies, and clients
Adheres at all times to physical, administrative and technical safeguards related to core business when executing job functions.
Attendance and is critical.
Adhering to company policies and procedures.
Possess a professional demeanor, focused on respectful communication, a positive and reliable attitude, and responsible behavior. This includes dressing appropriately, being punctual, maintaining composure, and demonstrating accountability for your actions.
Working outside of core business hours may be required.
Other duties as assigned.
Compliance with the provisions of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended (“HIPAA”).
Performance Criteria:
Success is defined by accurate and timely routing of referrals and reporting as well high levels of customer service.
Required Qualifications:
New Jersey Office ONLY:
Must be registered with the State of New Jersey Board of Pharmacy as a Pharmacy Technician.
Nevada Office ONLY:
Must have Nevada Pharmacy Technician License. Technician Trainee License, issued by the Nevada State Board of Pharmacy is permitted only for internal candidates striving to obtain their Nevada Pharmacy Technician license.
Arizona Office ONLY:
Pharmacy Technician License (requires national certification by PTCB or ExCPT), or Technician Trainee License, issued by the Arizona State Board of Pharmacy.
Pennsylvania Office ONLY:
All onsite employees must have PA Pharmacy Technician License.
ALL LOCATIONS:
Minimum 3-5 years pharmacy experience.
Some previous management experience preferred.
Individual must possess exemplary communication, organization, and time management skills.
Knowledge of ASPN network capabilities is also preferred.
Reliable and consistent attendance is required.
Asembia is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, natural origin, ethnicity, religion, gender, pregnancy, marital status, sexual orientation, gender identity and expression, citizenship, genetic disposition, disability or veteran's status or any other classification protected by State/Federal laws.
Auto-ApplyPatient Support Center Supervisor
Livingston, NJ jobs
Patient Support Center Supervisor
Department: Patient Support Center / Call Center
Reports To: Director Operations
FLSA: Exempt
The Pharmacies operating hours are 8:00 am - 11:00 pm EST Monday through Friday, and Saturday through Sunday 8:00 am - 8:00 pm EST.
Primary Function:
The incumbent is responsible for executing program requirements and managing daily workflow.
Job Scope and Major Responsibilities:
Managing the workflow of their employees and delegating tasks.
Hold engaging team meetings and/or one-on-ones routinely with Team Leads.
Monitor quality and performance of the team and demonstrate the ability to provide feedback in an effective manner that drives change in behavior and results.
Accomplishes staff job results by coaching, counseling, and disciplining employees.
Training and onboarding.
Work in conjunction with Management Team and the Quality Assurance Team to communicate productivity gaps and quality as it pertains to the program.
Interface with programmers as needed to address any system enhancements or difficulties.
Creating team schedules and time and attendance management.
Setting goals for workers and making sure they comply with the company's policies and procedures.
Identify potential training gaps, escalating these to site leadership.
Alert site leadership to any potential staff matters, including performance or behavioral issues.
Ensuring that business goals, deadlines and performance standards are met
Maintain tracking document and crosscheck to ensure platform/tracking document accuracy
Attend manufacturer meetings to support ongoing program development
Establish effective rapport with other employees, clients, physicians, pharmacies, and clients
Adheres at all times to physical, administrative and technical safeguards related to core business when executing job functions.
Attendance and is critical.
Adhering to company policies and procedures.
Possess a professional demeanor, focused on respectful communication, a positive and reliable attitude, and responsible behavior. This includes dressing appropriately, being punctual, maintaining composure, and demonstrating accountability for your actions.
Working outside of core business hours may be required.
Other duties as assigned.
Compliance with the provisions of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended (“HIPAA”).
Performance Criteria:
Success is defined by accurate and timely routing of referrals and reporting as well high levels of customer service.
Required Qualifications:
New Jersey Office ONLY:
Must be registered with the State of New Jersey Board of Pharmacy as a Pharmacy Technician.
Nevada Office ONLY:
Must have Nevada Pharmacy Technician License. Technician Trainee License, issued by the Nevada State Board of Pharmacy is permitted only for internal candidates striving to obtain their Nevada Pharmacy Technician license.
Arizona Office ONLY:
Pharmacy Technician License (requires national certification by PTCB or ExCPT), or Technician Trainee License, issued by the Arizona State Board of Pharmacy.
Pennsylvania Office ONLY:
All onsite employees must have PA Pharmacy Technician License.
ALL LOCATIONS:
Minimum 3-5 years pharmacy experience.
Some previous management experience preferred.
Individual must possess exemplary communication, organization, and time management skills.
Knowledge of ASPN network capabilities is also preferred.
Reliable and consistent attendance is required.
Asembia is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, natural origin, ethnicity, religion, gender, pregnancy, marital status, sexual orientation, gender identity and expression, citizenship, genetic disposition, disability or veteran's status or any other classification protected by State/Federal laws
.
Auto-ApplyTransformation Leader - External Manufacturing - Biologics
Framingham, MA jobs
Job Title: Transformation Leader - External Manufacturing - Biologics
About the Job
Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care.
The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU.
This positioning makes the Transformation Leader a “local transformation enabler”: ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU.
**This is a hybrid role - 3 days a week onsite - required. **
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Support Transformation Delivery
Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU.
Localize change strategies to fit the GBU context, culture, and priorities.
Act as a key point of contact for all change-related activities in the GBU.
Drive Adoption & Engagement
Ensure employees and managers understand the why, what, and how of transformation initiatives.
Develop and execute communication and training plans to maximize adoption.
Monitor adoption and embed new behaviors, processes, and tools into the GBU.
Stakeholder & Leadership Support
Build strong relationships with GBU leaders to support them as change sponsors.
Provide coaching and guidance to managers and teams to reinforce change behaviors.
Act as a trusted advisor to GBU leadership on change readiness and risks.
Change Measurement & Reporting
Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership.
Identify resistance, barriers, and adoption gaps, and proactively recommend solutions.
Capture lessons learned to continuously improve change implementation in the GBU.
About You
Bachelor's degree in Business, Human Resources, Organizational Development, or related field.
5+ years of experience in change management or organizational transformation.
Strong knowledge of CMO/CDMO manufacturing - Required.
Strong knowledge of change management frameworks
Demonstrated ability to work in complex, matrixed organizations.
Excellent communication, facilitation, and interpersonal skills.
Proven track record in supporting digital, operational, or organizational transformation programs.
Certification in Change Management or Project Management is a plus.
Key Competencies of a Transformation Leader
As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master:
Vision & Strategy
Strategic thinking: Ability to see the "big picture" and anticipate trends
Organizational alignment: Connect transformation to business objectives
Change Management
Change management: Master methodologies
Resistance management: Identify and address barriers to change
Change communication: Adapt messages to different audiences
Operational Competencies
Project/Program Management
Business acumen with ability to translate transformation into operational impact.
Problem-solving and analytical thinking.
Process optimization: Identify and implement improvements
Digital literacy: Understand emerging technologies (AI, automation, cloud)
Innovation: Promote experimentation and learning
Relational Competencies /Leadership & Influence
Cross-functional work: Orchestrate multi-functional teams
Inspirational leadership: Mobilize and engage teams
Influence without authority: Convince stakeholders at all levels and relationship building at GBU level.
Emotional intelligence: Understand and manage emotions during change change
Negotiation: Find compromises and create consensus
Soft Skills
Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling)
Empathy: Understand the human impact of change
Resilience and adaptability in dynamic environments.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Onsite
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$147,000.00 - $212,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Auto-ApplySupervisor Manufacturing
Exton, PA jobs
Manufacturing Manager Title: Manager, Manufacturing Operations Reports to: Vice President, PD & Manufacturing Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
* Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
* Manage a team of manufacturing technologists, operators, and warehouse coordinators.
* Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
* Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
* Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
* Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
* Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
* Write, review and approve SOP's, qualification protocols, and other GMP documentation.
* Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
* Implements site initiatives in production operation as advised by site management.
* Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
* Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
* Responsible for compliance monitoring of area operations.
* Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
* Process and analyze manufacturing results, data and provide status updates to the management.
* Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
* Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
* Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
* 5+ years of people management experience.
* Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
* Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
* Ability to perform frequent physical tasks with strength and mobility.
* Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Supervisor Manufacturing
Exton, PA jobs
Manufacturing Manager
Title: Manager, Manufacturing Operations
Reports to: Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
Manage a team of manufacturing technologists, operators, and warehouse coordinators.
Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
Write, review and approve SOP's, qualification protocols, and other GMP documentation.
Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
Implements site initiatives in production operation as advised by site management.
Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
Responsible for compliance monitoring of area operations.
Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
Process and analyze manufacturing results, data and provide status updates to the management.
Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
5+ years of people management experience.
Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
Ability to perform frequent physical tasks with strength and mobility.
Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Auto-ApplySupervisor Manufacturing
Exton, PA jobs
Job Description
Manufacturing Manager
Title: Manager, Manufacturing Operations
Reports to: Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
Manage a team of manufacturing technologists, operators, and warehouse coordinators.
Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
Write, review and approve SOP's, qualification protocols, and other GMP documentation.
Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
Implements site initiatives in production operation as advised by site management.
Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
Responsible for compliance monitoring of area operations.
Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
Process and analyze manufacturing results, data and provide status updates to the management.
Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
5+ years of people management experience.
Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
Ability to perform frequent physical tasks with strength and mobility.
Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Manufacturing Supervisor
Lakewood, NJ jobs
Job Description
Job Title: Manufacturing Supervisor
Hours: 2nd shift, Monday-Friday, 3:00pm-11:30pm
Join Our Team: At Accupac, we are Makers. From formulation to manufacturing, we serve the most trusted brands in the beauty and personal care industries with a wide range of cosmetics, over-the-counter and medical devices across skincare, haircare, oral care, and healthcare products.
But beyond that, we make a difference. We make a difference in the lives of our people, we make a difference in the community around us, we make a difference in the health of our planet for a better, brighter, more beautiful future for all.
We value safety-minded, detail-driven leaders who thrive in a fast-paced manufacturing environment and bring strong organizational and people management skills to production operations. As a Manufacturing Supervisor, you'll oversee the preparation, mixing, and production of high-quality products while ensuring all compounding processes meet safety, efficiency, and compliance standards in accordance with cGMPs, regulatory requirements, and company policies.
What We Offer:
· Competitive Pay
o Salary Range: $75,000.00 - $90,000.00
o Bonus: Exempt employees are eligible for a bonus in accordance with Accupac's Bonus Plan
o The posted job may span more than one career level. The final offer, including level and pay, will be determined based on a variety of factors such as the candidate's relevant job and industry experience, education, knowledge, skills, geographic location, and abilities. Internal equity and alignment with market data will also be considered. We are committed to providing fair and competitive compensation based on each candidate's qualifications and fit for the role.
· Employees are eligible for the following benefits:
o Medical, Dental, and Vision insurance
o Health Savings Account
o Life Insurance with Optional Supplemental Plan
o Pet Insurance
o Short-Term Paid Disability
o 401(k) Retirement Plan with Vested Company Match Contribution
o Paid Time Off (PTO)
o 10 Paid Holidays
o Health Advocacy Programs
· Career Growth
What You'll Do:
· Supervise and lead the compounding team in day-to-day operations, ensuring safe and efficient production
· Train staff on SOPs, GMPs, safety protocols, and customer-specific procedures
· Oversee mixing of raw materials according to formulation specifications and batch records
· Ensure compliance with cGMP, FDA, and internal quality standards through regular inspections and audits
· Maintain accurate and complete records of production, materials, and quality control checks
· Schedule and assign work to meet daily and weekly manufacturing targets
· Support troubleshooting of equipment and process issues, and implement corrective actions
· Coordinate preventative maintenance and calibration of departmental equipment
· Collaborate with internal teams including Quality, Project Management, and Maintenance
· Assist in performance evaluations, disciplinary actions, and interviewing new team members
· Participate in developing, reviewing, and editing departmental SOPs and procedures
· Promote a culture of safety, accountability, and continuous improvement
What We're Looking For:
· High school diploma or GED required
· Minimum 5 years of experience in manufacturing, with prior supervisory experience preferred
· Strong knowledge of cGMPs, FDA regulations, and manufacturing best practices
· Excellent communication and leadership skills with the ability to train, motivate, and supervise staff
· Proficiency in basic math and computer software including Microsoft Office
· Mechanical aptitude and ability to safely operate forklifts and pallet movers
· Able to work different shifts or overtime to meet manufacturing needs
Must meet physical requirements: lift/carry up to 50 lbs, perform repetitive tasks, stand/walk on concrete floors, work in dusty environments, and wear required PPE including respirators
Ready to Apply? Join us at Accupac and become part of a company that values your skills and dedication. Click below to apply today!
#INDOTHER2025
Manufacturing Supervisor
Lakewood, NJ jobs
Job Title: Manufacturing Supervisor
Hours: 2nd shift, Monday-Friday, 3:00pm-11:30pm
Join Our Team: At Accupac, we are Makers. From formulation to manufacturing, we serve the most trusted brands in the beauty and personal care industries with a wide range of cosmetics, over-the-counter and medical devices across skincare, haircare, oral care, and healthcare products.
But beyond that, we make a difference. We make a difference in the lives of our people, we make a difference in the community around us, we make a difference in the health of our planet for a better, brighter, more beautiful future for all.
We value safety-minded, detail-driven leaders who thrive in a fast-paced manufacturing environment and bring strong organizational and people management skills to production operations. As a Manufacturing Supervisor, you'll oversee the preparation, mixing, and production of high-quality products while ensuring all compounding processes meet safety, efficiency, and compliance standards in accordance with cGMPs, regulatory requirements, and company policies.
What We Offer:
· Competitive Pay
o Salary Range: $75,000.00 - $90,000.00
o Bonus: Exempt employees are eligible for a bonus in accordance with Accupac's Bonus Plan
o The posted job may span more than one career level. The final offer, including level and pay, will be determined based on a variety of factors such as the candidate's relevant job and industry experience, education, knowledge, skills, geographic location, and abilities. Internal equity and alignment with market data will also be considered. We are committed to providing fair and competitive compensation based on each candidate's qualifications and fit for the role.
· Employees are eligible for the following benefits:
o Medical, Dental, and Vision insurance
o Health Savings Account
o Life Insurance with Optional Supplemental Plan
o Pet Insurance
o Short-Term Paid Disability
o 401(k) Retirement Plan with Vested Company Match Contribution
o Paid Time Off (PTO)
o 10 Paid Holidays
o Health Advocacy Programs
· Career Growth
What You'll Do:
· Supervise and lead the compounding team in day-to-day operations, ensuring safe and efficient production
· Train staff on SOPs, GMPs, safety protocols, and customer-specific procedures
· Oversee mixing of raw materials according to formulation specifications and batch records
· Ensure compliance with cGMP, FDA, and internal quality standards through regular inspections and audits
· Maintain accurate and complete records of production, materials, and quality control checks
· Schedule and assign work to meet daily and weekly manufacturing targets
· Support troubleshooting of equipment and process issues, and implement corrective actions
· Coordinate preventative maintenance and calibration of departmental equipment
· Collaborate with internal teams including Quality, Project Management, and Maintenance
· Assist in performance evaluations, disciplinary actions, and interviewing new team members
· Participate in developing, reviewing, and editing departmental SOPs and procedures
· Promote a culture of safety, accountability, and continuous improvement
What We're Looking For:
· High school diploma or GED required
· Minimum 5 years of experience in manufacturing, with prior supervisory experience preferred
· Strong knowledge of cGMPs, FDA regulations, and manufacturing best practices
· Excellent communication and leadership skills with the ability to train, motivate, and supervise staff
· Proficiency in basic math and computer software including Microsoft Office
· Mechanical aptitude and ability to safely operate forklifts and pallet movers
· Able to work different shifts or overtime to meet manufacturing needs
Must meet physical requirements: lift/carry up to 50 lbs, perform repetitive tasks, stand/walk on concrete floors, work in dusty environments, and wear required PPE including respirators
Ready to Apply? Join us at Accupac and become part of a company that values your skills and dedication. Click below to apply today!
#INDOTHER2025
Team Leader I - Operations Training
Ashland, OH jobs
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
Job Summary
We are seeking a Team Leader I - Operations Training for our Safety Assessment site located in Ashland, OH.
Responsible for providing, coordinating, documenting and scheduling training sessions for onboarding and routine to highly complex training activities. Assist leadership team with the coordination for developing new technical training and for developing, revising, and implementing the use of training documents including SOP's and processes to support the overall company training program. Lead and mentor less experienced training personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES: (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
* Work with department management and lead, coordinate and/or provide technical training at all levels of complexity for in-vivo department personnel.
* Collaborate with Training Department management, cross-site personnel, and internal/external resources to develop and implement new training and improve the overall training program.
* Assist in providing, coordinating, and scheduling new hire orientation and on-the-job training for personnel.
* Ensure that all training provided meets quality and regulatory requirements. Provide additional training in these areas as needed.
* Assist with coordinating biannual review for maintaining, developing, and updating all documents and databases used for the support and conduct of training tasks including but not limited to training standards, training records training timelines, and proficiency standards.
* Perform technical tasks to support completion of study tasks (as needed).
* Practice/maintain advanced technical skills and procedures, work independently, and follow SOP's and processes.
* May conduct sponsor/visitor tours and interact with clients.
* Assist with the development, review, and/or revise current processes, SOP's, training standards, quizzes, proficiency standards, and other training documents.
* Lead and mentor less experienced training personnel.
* Assist supervisor in prioritizing workload and preparing schedule.
* Assist in the interview and selection of qualified non-exempt personnel. Assist in developing recommendations regarding personnel actions including hiring, promotions and raises.
* Ensure that department equipment is maintained in good working condition and that department area(s) are maintained in a clean and orderly condition.
* Serve as a model as it relates to effective time management, communication, and utilization of resources. Provide leadership and motivation to department personnel.
* Perform all other duties as assigned.
The pay range for this position is $26-30/hr per hour. Please note that starting salaries vary based on factors including, but not limited to, experience, skills, education, certifications, and location.
Job Qualifications
(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
* Education: High School diploma or General Education Degree (G.E.D.) required.
* Experience: 4 years related experience with a at least 2 years in a training capacity
* An equivalent combination of education and experience may be accepted in lieu of the specific education and experience listed above.
* Certification/Licensure: AALAS certification at the Assistant Laboratory Animal Technician (ALAT) level preferred.
* Other: Experience in the development of technical training programs and modules required. Experience in the delivery of instructor led training (ILT), synchronous on-line learning (e.g. webinars), and asynchronous (e-learning) methodologies preferred. Demonstrate advanced technical and analytical skills. Effective communication and leadership skills. Ability to handle a variety of laboratory animals. Proficient in technical skills and the operation of data collection equipment. Knowledge of GLP's and other federal regulations and guidelines relating to the care laboratory animals required. Understanding of basic, intermediate, and complex study design protocols. Ability to organize and prioritize work to meet deadlines. Computer literacy including word processing, spreadsheet, and database programs.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit ***************
231585
Easy ApplySupervisor, Sterile Filling (Midnight Shift)
Rochester, MI jobs
**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**
The Supervisor, Sterile Filling is responsible for daily coordination and
execution of working schedules of people and equipment in Sterile Filling. Responsible for supervising hourly union operators that conduct primary filling, lyophilization and/or terminal sterilization of a variety of drug and biological products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Responsible for direct supervision of one or more aseptic filling lines. Typically this will involve 3 to 6 operators per line. Supervisors are highly knowledgeable in cGMPs and good aseptic practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives.
In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
**Job Description**
Scope of Authority _-_
Supervisor of Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shift
**Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice**
Significant Equipment includes: Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers
Key Accountabilities
Operations
+ Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures
+ Develops daily/weekly department work schedules, set priorities and verifies availability of resources
+ Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization
+ Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation
+ Ensure all equipment is working properly
+ Reviews batch records and supporting records prior to submission to Quality
+ Maintains a safe work environment
+ Completes in-process, set up checks and verification in alignment with Standard Operating Procedures
20%
Compliance
+ Understands and adheres to good documentation practices (GDP)
+ Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
+ Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control
+ Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure
+ Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
+ Initiates and approves maximo work orders for equipment repairs or modifications
+ Creates, reviews and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety
+ Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance
+ Follow and comply with company Safety policies and OSHA Regulations
+ Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions
25%
Supervisory
+ Reports production updates and schedule changes to team and/or at daily Huddle or SMART meetings
+ Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback
+ Assigns manpower; initiates documentation of violations and disciplinary action with operators as required
+ Requests equipment and facility repairs, or modifications
+ Understands and complies with Union Agreement
+ Keeps manager informed of operations; elevates as needed
25%
Leadership
+ Reviews operational performance; drives improvement opportunities
+ Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication
+ Consistently communicate, follow and enforce SOP's and company policies and guidelines set forth in the employee handbook
+ Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieve
+ Interfaces with suppliers of equipment or products and area consultants/experts
+ Conducts/supports CMO audits or regulatory agency inspections
30%
Total
100%
Qualifications
Education & Experience
Education
+ Required- B.A. /B.S. Degree in Science, Business or related field or significant experience
+ Desired- B.A. /B.S. Degree in Packaging, Science and/or Management degree
Experience
+ Required - None
+ Desired - 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalent
Knowledge
+ Knowledge of Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, Maximo
+ Solid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA
+ Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc., can be considered after critical assessment of their industry related knowledge. Must be able to gain knowledge and expertise in aseptic processing
Skills
&
Abilities
To perform the job successfully, an individual should demonstrate the following competencies:
**For internal candidates: meets or exceeds expectations as follows:**
+ **Quality** - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
+ **Quantity** - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
+ **Safety and Security** - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
+ **Attendance/Punctuality** - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
+ **Dependability** - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
+ **Technical Skills** - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
+ **Interpersonal Skills** - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
+ **Written Communication** - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs and intended audience; Presents numerical data effectively; Able to read and interpret written information.
+ **Teamwork** - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed
+ **Analytical** **-** Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures
To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:
+ **Design** **-** Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
+ **Oral Communication** **-** Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
+ **Professionalism** **-** Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility/accountability for own actions; Follows through on commitments.
+ **Initiative** **-** Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
+ **Resilience** **-** Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
+ **Problem Solving** **-** Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
+ **Motivation** **-** Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
+ **Planning/Organizing** **-** Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
+ **Adaptability** **-** Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Physical & Work Requirements
+ Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5.
+ Stand, Walk, Sit, Talk and/or Hear
+ Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
+ Specific vision abilities required by this job include close vision
+ Frequently working near or exposed to moving mechanical parts
+ The noise level is moderate
+ Occasional exposure to fumes, airborne particles, toxic or caustic chemicals
+ Work environment is a production/manufacturing plant
**_Disclaimer:_** _The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and_ _qualifications._ _Management reserves the right to change or modify such duties as required._
**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.
Supvervisor, Sterile Filling (Afternoons)
Rochester, MI jobs
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
The Supervisor, Sterile Filling is responsible for daily coordination and execution of working schedules of people and equipment in Sterile Filling. Responsible for supervising hourly union operators that conduct primary filling, lyophilization and/or terminal sterilization of a variety of drug and biological products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Responsible for direct supervision of one or more aseptic filling lines. Typically this will involve 3 to 6 operators per line. Supervisors are highly knowledgeable in cGMPs and good aseptic practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives.
In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
Job Description
Scope of Authority
-
Supervisor of Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shift
Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice
Significant Equipment includes: Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers
Key Accountabilities
Operations
Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures
Develops daily/weekly department work schedules, set priorities and verifies availability of resources
Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization
Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation
Ensure all equipment is working properly
Reviews batch records and supporting records prior to submission to Quality
Maintains a safe work environment
Completes in-process, set up checks and verification in alignment with Standard Operating Procedures
20%
Compliance
Understands and adheres to good documentation practices (GDP)
Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control
Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure
Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
Initiates and approves maximo work orders for equipment repairs or modifications
Creates, reviews and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety
Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance
Follow and comply with company Safety policies and OSHA Regulations
Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions
25%
Supervisory
Reports production updates and schedule changes to team and/or at daily Huddle or SMART meetings
Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback
Assigns manpower; initiates documentation of violations and disciplinary action with operators as required
Requests equipment and facility repairs, or modifications
Understands and complies with Union Agreement
Keeps manager informed of operations; elevates as needed
25%
Leadership
Reviews operational performance; drives improvement opportunities
Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication
Consistently communicate, follow and enforce SOP's and company policies and guidelines set forth in the employee handbook
Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieve
Interfaces with suppliers of equipment or products and area consultants/experts
Conducts/supports CMO audits or regulatory agency inspections
30%
Total
100%
Qualifications
Education & Experience
Education
Required- B.A. /B.S. Degree in Science, Business or related field or significant experience
Desired- B.A. /B.S. Degree in Packaging, Science and/or Management degree
Experience
Required - None
Desired - 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalent
Knowledge
Knowledge of Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, Maximo
Solid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA
Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc., can be considered after critical assessment of their industry related knowledge. Must be able to gain knowledge and expertise in aseptic processing
Skills
&
Abilities
To perform the job successfully, an individual should demonstrate the following competencies:
For internal candidates: meets or exceeds expectations as follows:
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs and intended audience; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures
To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:
Design -Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility/accountability for own actions; Follows through on commitments.
Initiative -Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Resilience - Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
Problem Solving -Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Adaptability -Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Physical & Work Requirements
Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5.
Stand, Walk, Sit, Talk and/or Hear
Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
Specific vision abilities required by this job include close vision
Frequently working near or exposed to moving mechanical parts
The noise level is moderate
Occasional exposure to fumes, airborne particles, toxic or caustic chemicals
Work environment is a production/manufacturing plant
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
Auto-ApplyTeam Leader I - Operations Training
Ohio jobs
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
Job Summary
We are seeking a Team Leader I - Operations Training for our Safety Assessment site located in Ashland, OH.
Responsible for providing, coordinating, documenting and scheduling training sessions for onboarding and routine to highly complex training activities. Assist leadership team with the coordination for developing new technical training and for developing, revising, and implementing the use of training documents including SOP's and processes to support the overall company training program. Lead and mentor less experienced training personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES: (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
Work with department management and lead, coordinate and/or provide technical training at all levels of complexity for in-vivo department personnel.
Collaborate with Training Department management, cross-site personnel, and internal/external resources to develop and implement new training and improve the overall training program.
Assist in providing, coordinating, and scheduling new hire orientation and on-the-job training for personnel.
Ensure that all training provided meets quality and regulatory requirements. Provide additional training in these areas as needed.
Assist with coordinating biannual review for maintaining, developing, and updating all documents and databases used for the support and conduct of training tasks including but not limited to training standards, training records training timelines, and proficiency standards.
Perform technical tasks to support completion of study tasks (as needed).
Practice/maintain advanced technical skills and procedures, work independently, and follow SOP's and processes.
May conduct sponsor/visitor tours and interact with clients.
Assist with the development, review, and/or revise current processes, SOP's, training standards, quizzes, proficiency standards, and other training documents.
Lead and mentor less experienced training personnel.
Assist supervisor in prioritizing workload and preparing schedule.
Assist in the interview and selection of qualified non-exempt personnel. Assist in developing recommendations regarding personnel actions including hiring, promotions and raises.
Ensure that department equipment is maintained in good working condition and that department area(s) are maintained in a clean and orderly condition.
Serve as a model as it relates to effective time management, communication, and utilization of resources. Provide leadership and motivation to department personnel.
Perform all other duties as assigned.
The pay range for this position is $26-30/hr per hour. Please note that starting salaries vary based on factors including, but not limited to, experience, skills, education, certifications, and location.
Job Qualifications
(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
Education: High School diploma or General Education Degree (G.E.D.) required.
Experience: 4 years related experience with a at least 2 years in a training capacity
An equivalent combination of education and experience may be accepted in lieu of the specific education and experience listed above.
Certification/Licensure: AALAS certification at the Assistant Laboratory Animal Technician (ALAT) level preferred.
Other: Experience in the development of technical training programs and modules required. Experience in the delivery of instructor led training (ILT), synchronous on-line learning (e.g. webinars), and asynchronous (e-learning) methodologies preferred. Demonstrate advanced technical and analytical skills. Effective communication and leadership skills. Ability to handle a variety of laboratory animals. Proficient in technical skills and the operation of data collection equipment. Knowledge of GLP's and other federal regulations and guidelines relating to the care laboratory animals required. Understanding of basic, intermediate, and complex study design protocols. Ability to organize and prioritize work to meet deadlines. Computer literacy including word processing, spreadsheet, and database programs.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit ***************
Easy ApplyPartial/Outpatient Supervisor
Indiana, PA jobs
Serve as secondary contact with referral sources (including but not limited to internal departments and external providers) and facilitate admissions to programs. Ensure appropriateness of departmental admissions, and adhere to all relevant internal clinical pathways governing admissions. Maintain and complete authorizations for Partial/ALPHA.
Maintain and complete authorizations for Partial/ALPHA.
Coordinate and supervise in conjunction with department director clinical services as needed, including but not limited to, trainings and oversight for interns and clinical staff promoting social responsibility.
Assist with performance evaluations and disciplinary actions for staff as needed promoting growth and change. Collaborate with Director regarding outcomes and carry-out of disciplinary actions as needed.
Assist in developing and monitoring of departmental processes and company policies.
Provide back-up direct care to consumers, as needed, and perform administrative and clinical functions as needed using emotional intelligence.
Assist in handling day to day employee/consumer situations (including but not limited to call offs, complaints, scheduling, etc). Collaborate with Director to provide ongoing supervision of staff openly communicating any and all issues.
Ensure compliance with all program standards and regulations. Maintain current knowledge of regulations, standards, policies, etc. Maintain adequate and current records.
Attend any appropriate meetings in conjunction with current position. Fill in assigned duties in absence of department director utilizing social responsibility.
Pricing Supervisor
Lancaster, PA jobs
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Perform both technical and personnel aspects of group operations; performing work within the department or other areas as required; act as a technical resource, trainer, and troubleshooter to specific department, make recommendations for operational and/or technical improvements; communicate effectively within the group; coach and develop direct reports, plan and monitor workflow, monitor data and support departmental MOS; demonstrate and strengthen leadership qualities.
Work Standards:
Applies GMP/GLP in all areas of responsibility, as appropriate
Applies the highest quality standard in all areas of responsibility
Demonstrates and promotes the company vision
Demonstrates strong client service skills, teamwork, and collaboration
Proactively plans and multitasks to maximize productivity
Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
Regular attendance and punctuality
Support and promote company policies and procedures
Proactive and effective escalation to appropriate management
Ensure that the quality policy program is understood, implemented, and maintained; identify, prevent, or correct any departures from the quality system
Enforces safety policies across all areas of responsibility
Perform laboratory tasks as required to deliver on department objectives
Perform all functions in support of and in compliance with all state and federal employment regulations
Communicates effectively with client staff members
Conducts all activities in a safe and efficient manner
Performs other duties as assigned
Leader of Direct Reports:
Foster a positive and professional work environment
Communicate a clear vision and motivate staff to excel
Monitor and approve employees' time worked through time-entry system
Follow communication plan policy for regular meetings as directed by your business unit
Coach, train, and develop others within the group with respect to their personal development to maximize performance
Manage workflow and perform daily monitoring to meet customer service needs and KPI
Conduct semi-annual performance reviews and interview applicants
Perform training record review for direct reports
Ensure data integrity record keeping to maintain compliance
Confront and address problems, concerns and performance issues in real time
Expand self-awareness and develop leadership skills as defined; attend applicable leadership training based on identified needs
Effectively delegate and exercise accountability of self and others
Serve as floor supervisor on a daily basis, effectively transition from peer to leader
Participate in succession planning with supervisor in preparation for growth of team and self Customer Obsession: Support and coordinate information for calls/audits Numeracy: Basic understanding of quoting process. Identify and take action when pricing is inaccurate.
Qualifications
Minimum Qualifications:
Bachelor's degree required
Minimum 3 years' professional experience
Background or understanding of Client Pricing, Project Scope Creation, or Biopharmaceutical Analytical Testing
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position will be Full-Time, First Shift, 8am-5pm Monday-Friday.. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
What we Offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Pricing Supervisor
Lancaster, PA jobs
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Perform both technical and personnel aspects of group operations; performing work within the department or other areas as required; act as a technical resource, trainer, and troubleshooter to specific department, make recommendations for operational and/or technical improvements; communicate effectively within the group; coach and develop direct reports, plan and monitor workflow, monitor data and support departmental MOS; demonstrate and strengthen leadership qualities.
Work Standards:
Applies GMP/GLP in all areas of responsibility, as appropriate
Applies the highest quality standard in all areas of responsibility
Demonstrates and promotes the company vision
Demonstrates strong client service skills, teamwork, and collaboration
Proactively plans and multitasks to maximize productivity
Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
Regular attendance and punctuality
Support and promote company policies and procedures
Proactive and effective escalation to appropriate management
Ensure that the quality policy program is understood, implemented, and maintained; identify, prevent, or correct any departures from the quality system
Enforces safety policies across all areas of responsibility
Perform laboratory tasks as required to deliver on department objectives
Perform all functions in support of and in compliance with all state and federal employment regulations
Communicates effectively with client staff members
Conducts all activities in a safe and efficient manner
Performs other duties as assigned
Leader of Direct Reports:
Foster a positive and professional work environment
Communicate a clear vision and motivate staff to excel
Monitor and approve employees' time worked through time-entry system
Follow communication plan policy for regular meetings as directed by your business unit
Coach, train, and develop others within the group with respect to their personal development to maximize performance
Manage workflow and perform daily monitoring to meet customer service needs and KPI
Conduct semi-annual performance reviews and interview applicants
Perform training record review for direct reports
Ensure data integrity record keeping to maintain compliance
Confront and address problems, concerns and performance issues in real time
Expand self-awareness and develop leadership skills as defined; attend applicable leadership training based on identified needs
Effectively delegate and exercise accountability of self and others
Serve as floor supervisor on a daily basis, effectively transition from peer to leader
Participate in succession planning with supervisor in preparation for growth of team and self Customer Obsession: Support and coordinate information for calls/audits Numeracy: Basic understanding of quoting process. Identify and take action when pricing is inaccurate.
Qualifications
Minimum Qualifications:
Bachelor's degree required
Minimum 3 years' professional experience
Background or understanding of Client Pricing, Project Scope Creation, or Biopharmaceutical Analytical Testing
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position will be Full-Time, First Shift, 8am-5pm Monday-Friday.. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
What we Offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Copy Supervisor - HCP
Boston, MA jobs
at Havas Health & You
Havas Health & You Mission: To be the world's best company at creating meaningful connections using creativity, media, and innovation to inspire healthier lives. HavasHealthandYou.com
JOB TITLE: Senior Copywriter - Healthcare HCP (Healthcare Professional/Provider)
We are looking for YOU.
THE ROLE
This is a Senior Copywriter position in pharmaceutical promotional marketing communications targeted to healthcare professionals - physicians and nurses.
You will learn to develop general medical knowledge in therapeutic areas
You will learn how to prepare and annotate references for submission to client's medical/legal review process
You will write copy for assigned projects that are on strategy and wow your team and clients
Assignments could include print ads, websites, visual aides/eDetailing, email, video and collateral materials
MUST HAVE
Please only apply if you have the following:
approximately 3 -5 years experience in advertising agencies
Portfolio of work demonstrating conceptual capabilities in both digital and print mediums (can be student/spec work) including high science writing
Bachelor's Degree in a related field - advertising, writing, journalism, science
We are an equal opportunity employer and value diversity at our company.
Auto-Apply