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Job Description

OBJECTIVE:

Responsible for supporting the cell line development (CLD) team through participation in transfection, stable selection, cloning, expansion, characterization of mammalian cell lines for clinical and commercial production, as well as automation, data processing and digitalization. This position will perform laboratory experiments using a variety of CLD and cell culture technologies including single cell cloning/clone picking, cell imaging, liquid handling automation and Octet/ELISA-based recombinant protein quantification. The candidate will need strong organizational skills and experience with a variety of data and digital tools for review and interpretation of data and its use in models to improve CLD outcomes. . Programming skills with Python, R, etc. is a plus. This position will be expected to conduct experiments with supervision, document experimental steps in an electronic laboratory notebook, and draft support documentation.

ACCOUNTABILITIES:

• Familiar with molecular biology and cell culture techniques, previous CHO cell line development experience is appreciated
  
• Familiar with general laboratory procedures and aseptic technique.
  
• Contributes directly to project work which may include multiple projects within functional area and presents data in group meetings
  
• Identifies technical issues and implements solutions under supervision.
  
• Support technology development projects as well as cell line development for pipeline molecules under supervision.
  
• Prepares experimental protocols and keeps good records of experiments
  
• Coordinates within department as well as cross functionally with peers on projects.
  
• Experience with data and digital applications and programing language will be a plus
  
• Experience with automation, FACS, ddPCR and Next-Gen Sequencing will be a plus
  

EDUCATION, EXPERIENCE AND SKILLS:

• Bachelor’s degree in biochemistry, molecular biology, biotechnology, or related pharmaceutical science; 1+ years of biotechnology/biopharmaceutical industry experience, preferably in cell line development
  
• Master’s degree in biochemistry, molecular biology, biotechnology, or related pharmaceutical science
  

Knowledge and Skills:

• Learning Skills - Able to learn different procedures under supervision or from protocols, has attention to details to identify and solve problems
  
• Teamwork - Ability to work within department groups/team.
  
• Communication Skills - Expresses oneself clearly and concisely within function; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor
  
• Organization - Exercises good time management skills
  
• Technical - Proficient in use of applicable lab equipment and operations
  

Physical Demands:

Cell culture technique does involve some repetitive motion.

LINE FUNCTION SPECIFIC QUALIFICATIONS:

Biologics - Upstream Process Development: Cell line development:

• Sound knowledge of cell culture principles, experience in aseptic techniques required
  
• Experience in CLD technologies including culture of mammalian cells, single cell cloning (sorting/clone picking), clonality assessment, and clone screening highly desirable
  
• Experience in molecular biology methods including subcloning, northern blot, RT-qPCR/ddPCR and Octet/ELISA-based recombinant protein quantification is desirable
  

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Boston, MA

U.S. Hourly Wage Range:
$26.92 - $42.31

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based e mployee s may be eligible for s hort - t erm incentives . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt
No

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Data Reviewer to join our Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you!

Responsibilities

• Comprehensive manual review of clinical data collected in trials;
• Development of clinical review guidelines for specific therapeutic areas;
• Interface with Data Management team to assure query resolution.
• Seeking specialization in following therapeutic areas:
  • Cardiology
  • Infectious Disease
  • Oncology
  • Endocrine

*Stable schedule with no weekends, no work on Medpace holidays, and flexible work schedule*

Qualifications

• Bachelor's of Science in Nursing and RN required,
• At least 3-4 years of nursing experience
• 1-2 years of specific therapeutic experience
• General knowledge of clinical trial processes and/or experience working with clinical data; and
• Familiarity with Microsoft Excel preferred.

TRAVEL: None

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

• Cincinnati Campus Overview
• Flexible work environment
• Competitive PTO packages, starting at 20+ days
• Competitive compensation and benefits package
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Discounts on local sports games, fitness gyms and attractions
• Modern, ecofriendly campus with an on-site fitness center
• Structured career paths with opportunities for professional growth
• Discounted tuition for UC online programs

Awards

• Named a Top Workplace in 2024 by The Cincinnati Enquirer
  
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Job description:

We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you. 

 

We are currently recruiting for a Senior Scientist to join the Analytical Development and Technologies group.  The purpose of this role is to perform and manage analytical projects (CMC) encompassing assay development, qualification, validation, and QC implementation and to support other members of the team as needed to help the delivery of team goals and client work packages. 

 

Your responsibilities in this role would be: 

 

• Responsible for leading the development, transfer, qualification, and validation of assays for testing lentiviral vectors for various cell and gene therapy products at different stages of clinical development.
• Manage and/or execute the delivery of work packages to clients while keeping up to date communications with client in meetings, internal project managers and other departments, with supervision from Group Leads.
• Write and review technical documents such as study documentation, qualification/validation plans and reports, SOPs etc.
• Act as an SME (Subject Matter Expert) in at least one type of assay from cell-based, qPCR/ddPCR, ELISA or HPLC: scientific and technical expertise, assist on troubleshooting and as a representative in cases of assay investigations (i.e. deviations from procedure, change controls, etc.) and discussions with client teams.
• Ensure robust technical transfer of methods to QC (Quality Control) and other departments/sites.
• Aspire to innovate within the team and company by bringing new ideas and concepts in all aspects of assay lifecycle for viral vectors.
• Support and mentor other scientists within the department. 

 

We are looking for: 

 

• BSc, MSc or PhD in a Biosciences field or similar.
• Relevant laboratory experience in two or more of the following assay types: tissue culture, cell-based assays, qPCR/ddPCR, molecular biology, ELISA or HPLC.
• Experience in managing and delivering scientific/technical projects to defined objectives and timelines.
• Experience in liaising and communicating with different stakeholders, including external partners, clients or collaborators is an advantage.
• Experience in working or being exposed to a regulated GxP environment is an advantage.
• Knowledge/experience in virology and/or gene therapy products is an advantage. 
• Understanding of basic statistics in experimental data analysis and/or AQbD/DOE.
• Competency in data capture, documenting and reporting scientific/technical studies.
• Ability to work accurately in a busy and demanding environment, and to manage competing priorities.
• Credible and confident communicator (written & verbal) at all levels.
• Self-motivated with the ability to work proactively using own initiative.
• Demonstrates ability to work well in a team as well as independently.
• High level of familiarity with Microsoft Office. 

 

 

About Us: 

 

Oxford Biomedica is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.

 

Oxford Biomedica collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise

 

 

What’s in it for you: 

 

• Highly competitive total reward packages 
• Wellbeing programmes 
• Development opportunities 
• Welcoming, friendly, supportive colleagues 

• A diverse and inclusive working environment 
• Our values are: Deliver Innovation, Be Inspiring and Have Integrity 
• State of the art laboratory and manufacturing facilities 

 

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you. 

 

Collaborate. Contribute. Change lives

We offer:

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

 

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

 

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.

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