Senior Group Leader - Biopharm - HPLC (SEC , IEX)

Submission for the position: Senior Group Leader - Biopharm - HPLC (SEC , IEX) - (Job Number: 167191)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.

This position will be on a client site in their analytical development group for new biological entities (NBEs) which develops antibody drug conjugates (ADC) and other biologics using state of the art analytical technologies. As part of this group you will prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.

We are looking for a highly motivated person who can lead the analytical development of new biologic candidates from FIH through registration. In this role you will be responsible for executing activities required for analytical development. You must be able to mentor junior staff with novel experimental approaches to answer scientific questions to develop and optimize NBE drug product formulations. Working closely with formulation and process development scientists, you will develop productive collaborations and communications with scientific teams.

Responsibilities:Design, execute and assess experimental data for analytical characterization, formulation/process development samples and clinical trial supplies (e.g. GMP compliant stability and batch release testing).Support development of therapeutic proteins at various stagesAuthor and/or review key regulatory documents, laboratory data, technical memos and reports.Support activities associated with formulation/process development design and characterization for new biologic compounds.

Mentor small project team(s) in the execution and design experiments for method development and validation studies.Mentor junior staff in troubleshooting of equipment and experimental problems.Encourage ideas for continuous improvement activities and initiatives within work group.Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

Provides management and direction to laboratory staff and resources for project activities and needs, oversee daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs. Ensures responsiveness to the customer and overall, client satisfaction. PPDFSP

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.

This position will be on a client site in their analytical development group for new biological entities (NBEs) which develops antibody drug conjugates (ADC) and other biologics using state of the art analytical technologies. As part of this group you will prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.

We are looking for a highly motivated person who can lead the analytical development of new biologic candidates from FIH through registration. In this role you will be responsible for executing activities required for analytical development. You must be able to mentor junior staff with novel experimental approaches to answer scientific questions to develop and optimize NBE drug product formulations. Working closely with formulation and process development scientists, you will develop productive collaborations and communications with scientific teams.

Responsibilities:Design, execute and assess experimental data for analytical characterization, formulation/process development samples and clinical trial supplies (e.g. GMP compliant stability and batch release testing).Support development of therapeutic proteins at various stagesAuthor and/or review key regulatory documents, laboratory data, technical memos and reports.Support activities associated with formulation/process development design and characterization for new biologic compounds.

Mentor small project team(s) in the execution and design experiments for method development and validation studies.Mentor junior staff in troubleshooting of equipment and experimental problems.Encourage ideas for continuous improvement activities and initiatives within work group.Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

Provides management and direction to laboratory staff and resources for project activities and needs, oversee daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs. Ensures responsiveness to the customer and overall, client satisfaction. PPDFSP

Education and Experience:Bachelor's degree 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 and relevant combination of education, training, and experience.1 year of leadership responsibilityKnowledge, Skills and Abilities:Proven leadership skillsExperience in analytical methodology, such as chromatography, KF, UV and compendial methods and bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and LC-MS).Experienced in laboratory systems (LIMS, CDS, ELN) preferred.Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.

Ability to cultivate a collaborative work environment with a teamEffective negotiating skillsDemonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPsAbility to troubleshoot multiple systems/methodologiesAbility to independently optimize analytical methodsUnderstanding of basic financial terms and definitions as it applies to the businessUnderstanding of proposal and project scope as it relates to pricing, resource management and the impact on businessProject and time management skillsEffective written and oral communication skills as well as presentation skillsWorking Conditions:

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 35 poundsAble 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 typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities Regular and Consistent Attendance

Education and Experience:Bachelor's degree 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 and relevant combination of education, training, and experience.1 year of leadership responsibilityKnowledge, Skills and Abilities:Proven leadership skillsExperience in analytical methodology, such as chromatography, KF, UV and compendial methods and bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and LC-MS).Experienced in laboratory systems (LIMS, CDS, ELN) preferred.Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.

Ability to cultivate a collaborative work environment with a teamEffective negotiating skillsDemonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPsAbility to troubleshoot multiple systems/methodologiesAbility to independently optimize analytical methodsUnderstanding of basic financial terms and definitions as it applies to the businessUnderstanding of proposal and project scope as it relates to pricing, resource management and the impact on businessProject and time management skillsEffective written and oral communication skills as well as presentation skillsWorking Conditions:

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 35 poundsAble 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 typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities Regular and Consistent Attendance

Submission for the position: Senior Group Leader - Biopharm - HPLC (SEC , IEX) - (Job Number: 167191)