About the job

Job description:

QC Bioassay/Biochemical Assay Team Lead The QC Bioassay Team Lead will be responsible for carrying out tasks and projects related to Bioassay and Immunoassay, in process, release and stability testing of biotechnology products as required by (GMP) Good Manufacturing Practice. They will lead a range of technical projects and activities in the QC Bioassay/ Biochemical group at WuXi biologics. The site is focused on start-up activities involving commissioning and qualification aligned with project timelines. As part of the project the role will evolve based on project timelines. Department DescriptionAs QC Bioassay Team Lead, you’ll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role, you’ll be reporting to the QC Bioassay Group Lead. Essential Duties & Responsibilities
Key member of the QC Team in Dundalk. Will support execution of the strategy and business planning processes, ensuring cross-functional collaboration.
From a QC functional capacity, support the design, construction, and commissioning of the new facility for the production of drug substance.
Support the development of a Biologics QC Bioassay and Biochemistry team including planning, recruiting/hiring, coaching/mentoring, and training.
Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs and safety regulations.
Communicate, collaborate, and cooperate with QC functional teams and other departments to support Lab start-up and routine operations.
Serve as technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviation, and CAPAs. controls, deviation, and CAPAs.
Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.
Support Risk Assessments for projects and business innovations initiatives from a bioassay/biochemistry perspective.
Ability to work in a team environment including but not limited cross-functional teams and independently as required.
Aligned with the project timelines managing and leading a team will also be required as part of the role
Prepare, review, and approve technical documents including method protocol, qualification and validation protocols and reports, etc.
Ensure that all Bioassay and Biochemistry testing is completed, reviewed, and approved within agreed turnaround times.
Ensure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
Initiate and drive change controls to completion to implement process improvements/improve operation excellence.
Actively participates in lean initiatives such as Kaizen, 5S and Gemba.
Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Bioassay Group Lead.
Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.
Person Specification: Qualifications
University degree in related science/quality discipline required.
Technical Competencies
Experience working in a QC function in a ‘greenfield’ context of similar size and scale is ideal.
Expertise in the release of GMP materials and participant in QC activities, such as method transfer, validation etc.
Previous experience handling regulatory inspections from FDA, EMA, etc. and GMP audits from clients as well as internal Quality Assurance is advantageous.
Experience working in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related fields is desirable.
Technical expertise in technical transfer, validations, qualifications and troubleshooting Biologics product- testing methods including but not limited to Bioassay, Cell Based Bioassays, Immunoassays, and qPCR to support QC release and stability testing in GMP-environment according to USP, EP, and ChP requirements is preferred.
Knowledge/Experience
Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals
More than 8 years’ experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
Previous experience managing and leading a small team would be advantageous.
Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required
Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project is required
Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable.
Previous experience working in a CMO is an advantage.
Behavioural Competencies
Strong leadership competencies with demonstrated management skills.
Excellent interpersonal, verbal, and written communication skills.
Able to think critically and demonstrate troubleshooting and problem-solving skills.
Self-starter and self-motivated; organized with good attention to detail.
Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
Results oriented, with the ability to manage multiple priorities in a short period of time.
Collaborative and inclusive approach to work and your colleagues.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now! Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via talentacquisition@wuxibiologics.com WuXi Biologics is an equal opportunities employer.

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Responsibilities

About the job

Job description:

QC Bioassay/Biochemical Assay Team Lead The QC Bioassay Team Lead will be responsible for carrying out tasks and projects related to Bioassay and Immunoassay, in process, release and stability testing of biotechnology products as required by (GMP) Good Manufacturing Practice. They will lead a range of technical projects and activities in the QC Bioassay/ Biochemical group at WuXi biologics. The site is focused on start-up activities involving commissioning and qualification aligned with project timelines. As part of the project the role will evolve based on project timelines. Department DescriptionAs QC Bioassay Team Lead, you’ll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role, you’ll be reporting to the QC Bioassay Group Lead. Essential Duties & Responsibilities
Key member of the QC Team in Dundalk. Will support execution of the strategy and business planning processes, ensuring cross-functional collaboration.
From a QC functional capacity, support the design, construction, and commissioning of the new facility for the production of drug substance.
Support the development of a Biologics QC Bioassay and Biochemistry team including planning, recruiting/hiring, coaching/mentoring, and training.
Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs and safety regulations.
Communicate, collaborate, and cooperate with QC functional teams and other departments to support Lab start-up and routine operations.
Serve as technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviation, and CAPAs. controls, deviation, and CAPAs.
Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.
Support Risk Assessments for projects and business innovations initiatives from a bioassay/biochemistry perspective.
Ability to work in a team environment including but not limited cross-functional teams and independently as required.
Aligned with the project timelines managing and leading a team will also be required as part of the role
Prepare, review, and approve technical documents including method protocol, qualification and validation protocols and reports, etc.
Ensure that all Bioassay and Biochemistry testing is completed, reviewed, and approved within agreed turnaround times.
Ensure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
Initiate and drive change controls to completion to implement process improvements/improve operation excellence.
Actively participates in lean initiatives such as Kaizen, 5S and Gemba.
Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Bioassay Group Lead.
Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.
Person Specification: Qualifications
University degree in related science/quality discipline required.
Technical Competencies
Experience working in a QC function in a ‘greenfield’ context of similar size and scale is ideal.
Expertise in the release of GMP materials and participant in QC activities, such as method transfer, validation etc.
Previous experience handling regulatory inspections from FDA, EMA, etc. and GMP audits from clients as well as internal Quality Assurance is advantageous.
Experience working in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related fields is desirable.
Technical expertise in technical transfer, validations, qualifications and troubleshooting Biologics product- testing methods including but not limited to Bioassay, Cell Based Bioassays, Immunoassays, and qPCR to support QC release and stability testing in GMP-environment according to USP, EP, and ChP requirements is preferred.
Knowledge/Experience
Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals
More than 8 years’ experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
Previous experience managing and leading a small team would be advantageous.
Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required
Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project is required
Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable.
Previous experience working in a CMO is an advantage.
Behavioural Competencies
Strong leadership competencies with demonstrated management skills.
Excellent interpersonal, verbal, and written communication skills.
Able to think critically and demonstrate troubleshooting and problem-solving skills.
Self-starter and self-motivated; organized with good attention to detail.
Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
Results oriented, with the ability to manage multiple priorities in a short period of time.
Collaborative and inclusive approach to work and your colleagues.