Biologics Process Sciences Leader

Reference #: 404512
Site Name: Rockville Biopharm, Upper Merion
Posted Date: Sep 27 2024

Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical manufacturing?  If so, this Biologics Process Sciences Leader role could be an ideal opportunity to explore.

As a Biologics Process Sciences Leader, you will be responsible for technical leadership of important programs of work to support lifecycle changes. The role provides leadership across process sciences, a CRO, an NPI or commercial site, or a CDMO to ensure that the studies are completed to the latest regulatory, cGMP requirements and time and cost.  The Biologics Process Sciences Leader is responsible for cell culture and purification process development and characterization studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Using regulatory guidance and industry best practice, and scientific and technical judgement, to develop innovative approaches to process development, characterization, and validation studies.
Plans, executes and reports process or viral clearance studies through process sciences, CROs, internal NPI or commercial DS sites or strategic CDMOs.
Authors regulatory submissions, responds to health authority information requests and presents at pre-approval & cGMP inspections as necessary.
Participates in deviation, change & continuous improvement evaluations in support of continued lifecycle verification.
Participates in the development & implementation of new process and analytical manufacturing technologies in support of biologics DS processes.
Manages CRO orCDMO contracts, and the effective management of expenditure and effort in support of process or viral clearance studies.
Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate.
Provides technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D.
Why you?

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BSc in Scientific Discipline
Minimum 5 years demonstrated experience in the Pharmaceutical Industry in leading the technical aspects of the product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ, CPV and change control.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Experienced in process development, characterization and validation at commercial scale and bench scale.
Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
Excellent problem solver and ability to think and work creatively.
Demonstrated knowledge of Quality by Design and risk management approaches.
Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
Broad and integrated knowledge that can impact project and workgroup direction. Working knowledge of regulatory requirements in the industry and drug development.
Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.
Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of produ t lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management.
Ability to support due diligences.
#LI-GSKThe annual base salary for new hires in this position ranges from $129,200 to $174,800 taking into account a number of factors including work location within the US market, the candidates skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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