Senior Project Manager - CMC , Cell and Gene Therapy , GxP

Submission for the position: Senior Project Manager - CMC , Cell and Gene Therapy , GxP - (Job Number: 189134)

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 clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients 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 a Senior Project Manager,you will support the Cell and Gene Therapy group while working onsite at a major pharmaceutical customer site.

Responsibiliites include:

Work independently and with the team to develop a CMC cell and gene therapy technical development project plan from current stage through product launch.

Manage the execution of CMC deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies.

Build and sustain robust business processes to support cross-functional clinical trial execution.

Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).

Facilitate regular project team meetings, issue written minutes, and follow up on action items.

Maintain overall project dashboard, schedule, budget, risk register, project plans, operational plans, and routine reports to sponsors and stakeholders.

Represent company to external partners groups as required

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 clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients 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 a Senior Project Manager,you will support the Cell and Gene Therapy group while working onsite at a major pharmaceutical customer site.

Responsibiliites include:

Work independently and with the team to develop a CMC cell and gene therapy technical development project plan from current stage through product launch.

Manage the execution of CMC deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies.

Build and sustain robust business processes to support cross-functional clinical trial execution.

Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).

Facilitate regular project team meetings, issue written minutes, and follow up on action items.

Maintain overall project dashboard, schedule, budget, risk register, project plans, operational plans, and routine reports to sponsors and stakeholders.

Represent company to external partners groups as required

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 sciences, bioengineering, or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience. 3 years of demonstrated project management and change management experience in a clinical pharma/biotech setting

Preferred Experience: PMP Certification Previous Regulatory and/or Tech Transfer experience Experience in cell therapy or gene therapy or combination products

Knowledge, Skills and Abilities: Experience in clinical phase drug development with hands on experience in GMP/GXP environment Strong science and/or business acumen Strong interpersonal skills to elicit, synthesize, and manage the cross-functional inputs required for a robust development plan Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business professionals Method Development and Method Validation in GMP required Strong verbal, written and presentation skills Superior time management, planning, and organizational skills Proven analytical skills Demonstrated compliance with procedures and policies Ability to perform multiple tasks effectively in a stressful environment Extensive knowledge and experience in Project Management Strong client relationship management skills Ability to work effectively with multi-level teams Ability to work in a fast-paced undefined environment

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.

*LI-NW1

Education and Experience: Bachelor's degree in life sciences, bioengineering, or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience. 3 years of demonstrated project management and change management experience in a clinical pharma/biotech setting

Preferred Experience: PMP Certification Previous Regulatory and/or Tech Transfer experience Experience in cell therapy or gene therapy or combination products

Knowledge, Skills and Abilities: Experience in clinical phase drug development with hands on experience in GMP/GXP environment Strong science and/or business acumen Strong interpersonal skills to elicit, synthesize, and manage the cross-functional inputs required for a robust development plan Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business professionals Method Development and Method Validation in GMP required Strong verbal, written and presentation skills Superior time management, planning, and organizational skills Proven analytical skills Demonstrated compliance with procedures and policies Ability to perform multiple tasks effectively in a stressful environment Extensive knowledge and experience in Project Management Strong client relationship management skills Ability to work effectively with multi-level teams Ability to work in a fast-paced undefined environment

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.

*LI-NW1 Submission for the position: Senior Project Manager - CMC , Cell and Gene Therapy , GxP - (Job Number: 189134)