Principal Program/Proj Manager - Quality Control , Stability , GMP

Submission for the position: Principal Program/Proj Manager - Quality Control , Stability , GMP - (Job Number: 176944)

In labs and health care facilities worldwide - HERE WE ARE

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our customers through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our customers to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As aPrincipal Program/Project Manager, you will contribute independently and strategically. You will plan and implement initiatives for stability program. Additionally, youwill oversee the customer's stability program for compliance with Stability ICH/FDA/EMA Guidelines. This role will provide leadership to QC analysts and specialists.

Additional responsibilities for the role on site at a major biopharmaceutical company: Oversee all aspects of stability study execution Contribute to the development of relevant SOPs, protocols, reports and stability sections for regulatory submission Work closely with Manufacturing, Quality Control and Quality Assurance to scheduleand coordinate activities required to execute product stability studies Work closely with Regulatory and Clinical Operations to coordinate activities required to support product throughout clinical studies Serve as a technical lead for, and contribute to writing of, stability related Quality Incidents, Deviations, Investigations, CAPAs and Change Controls Perform data review and statistical analyses to establish, extend and/or support expiration dates Work closely with vendors to expense and manage outsourced testing At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

In labs and health care facilities worldwide - HERE WE ARE

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our customers through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our customers to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As aPrincipal Program/Project Manager, you will contribute independently and strategically. You will plan and implement initiatives for stability program. Additionally, youwill oversee the customer's stability program for compliance with Stability ICH/FDA/EMA Guidelines. This role will provide leadership to QC analysts and specialists.

Additional responsibilities for the role on site at a major biopharmaceutical company: Oversee all aspects of stability study execution Contribute to the development of relevant SOPs, protocols, reports and stability sections for regulatory submission Work closely with Manufacturing, Quality Control and Quality Assurance to scheduleand coordinate activities required to execute product stability studies Work closely with Regulatory and Clinical Operations to coordinate activities required to support product throughout clinical studies Serve as a technical lead for, and contribute to writing of, stability related Quality Incidents, Deviations, Investigations, CAPAs and Change Controls Perform data review and statistical analyses to establish, extend and/or support expiration dates Work closely with vendors to expense and manage outsourced testing At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

Education and Experience: Bachelor's degree in life or physical sciences with a preference in Biology, Biochemistry, Pharmaceutical Science or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’) or equivalent combination of education, training, & experience.

Preferred Experience: 5 years’ experience in biopharmaceutical product stability with experience overseeing a stability program. 10 years of recent professional experience in a QC lab with 2-4 years supervisory experience Experience drafting stability protocols, writing stability sections for regulatory filings with a strong understanding for the guidelines Expertise in stability guidance documents, GMP documentation and pharmaceutical quality systems Experience with biological and/or chemical assays preferred Experience with analytical equipment troubleshooting preferred

Knowledge, Skills and Abilities: Knowledgeable in most or all the following techniques: Particle Size, Peptide Map, Reverse Phase, SEC, CEX, SDS-PAGE, Bioanalyzer, pH, Osmolality and other standard wet chemistry methods Proficiency with Microsoft Word, Excel, JMP and PowerPoint Ability to work with minimal supervision as well as in a team environment Strongorganizational and presentation skills Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes: Personal flexibility and a proactive orientation; Ability to handle multiple priorities. Ability to work under time and resource constraints. Commitment to excellence and high standards.

Working Environment: 

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.   Able to work upright and stationary and/or standing for typical working hours.   Able to lift and move objects up to 25 pounds   Able to work in non-traditional work environments.   Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.    

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.  

Keywords: stability , QC, "quality control" , GMP , HPLC , "QC Supervisor" , "stability supervisor"

*LI-NW1

Education and Experience: Bachelor's degree in life or physical sciences with a preference in Biology, Biochemistry, Pharmaceutical Science or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’) or equivalent combination of education, training, & experience.

Preferred Experience: 5 years’ experience in biopharmaceutical product stability with experience overseeing a stability program. 10 years of recent professional experience in a QC lab with 2-4 years supervisory experience Experience drafting stability protocols, writing stability sections for regulatory filings with a strong understanding for the guidelines Expertise in stability guidance documents, GMP documentation and pharmaceutical quality systems Experience with biological and/or chemical assays preferred Experience with analytical equipment troubleshooting preferred

Knowledge, Skills and Abilities: Knowledgeable in most or all the following techniques: Particle Size, Peptide Map, Reverse Phase, SEC, CEX, SDS-PAGE, Bioanalyzer, pH, Osmolality and other standard wet chemistry methods Proficiency with Microsoft Word, Excel, JMP and PowerPoint Ability to work with minimal supervision as well as in a team environment Strongorganizational and presentation skills Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes: Personal flexibility and a proactive orientation; Ability to handle multiple priorities. Ability to work under time and resource constraints. Commitment to excellence and high standards.

Working Environment: 

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.   Able to work upright and stationary and/or standing for typical working hours.   Able to lift and move objects up to 25 pounds   Able to work in non-traditional work environments.   Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.    

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.  

Keywords: stability , QC, "quality control" , GMP , HPLC , "QC Supervisor" , "stability supervisor"

*LI-NW1 Submission for the position: Principal Program/Proj Manager - Quality Control , Stability , GMP - (Job Number: 176944)