ReciBioPharm, the biologics business unit of Recipharm AB, is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients.  We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. ReciBioPharm’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives. 

 

JOB SUMMARY

Arranta Bio is seeking a talented individual to join our Continuous Manufacturing of mRNA Group (CMRG) in Watertown, MA. As a member of the elite CMRG team, this individual will be an integral member of the industry leading continuous manufacturing team supporting the Arranta’s mission of creating mRNA CM production lines capable of Real Time Release Testing (RTRT). Specifically, the role will focus on the development and validation of Process Analytical Technology (PAT) methods and data models, statistical data analysis including the justification for sampling plans, Monte Carlo simulations, etc., and the evaluation of new technology.

ESSENTIAL JOB FUNCTION

  • You will have the opportunity to work in a dynamic and enthusiastic atmosphere, whilst leading in the development and application of process analytical technology to enable enhanced control strategies in support of building the world’s first continuous mRNA RTRT production line.
  • You will work closely with a team of colleagues in a multi-skilled environment to design, develop and deliver high quality PAT methods including model predictive controls, advanced process control, multi-variate data analytics, and predictive models.
  • Continuous improvement will be at the core of everything you do, and you will drive the strategy in the PAT and advanced process control (including model predictive controls/APC/MVDA) area, to ensure that our organization will be on the frontline of emerging technologies and tools, including continuous manufacturing & digital transformation.
  • Examples of typical tasks: Serve as a senior expert/leader within CMRG, mentor colleagues in the field of enhanced control strategies and PAT. Drive the scientific knowledge synergy of PAT, PAT method development, and design enhanced control strategies, manufacturing & process technology and process control.
  • Take responsibility for the quality, reputation, communication and delivery of PAT science in cross-functional teams.
  • Provide strategic direction and advice on new science and technology within the scientific area of enhanced control strategies with PAT, taking part in tech transfer of these advanced analytical methods and giving consultation to internal and external parties, including regulatory authorities.
  • Continue to develop and drive scientific excellence in the area and advanced process control methodologies and technologies within the company as well as with world leading universities, scientific organizations and other industrial partners.

Experience and Skills

  • PhD within the field of Process Analytical Technology (PAT), advanced process control and/or chemometrics, analytical sciences or similar field, ideally with specialism in an area relevant to application of PAT to support continuous manufacturing.
  • Demonstrated delivery of PAT including advanced process control/MVDA, model predictive controls in support of pharmaceutical continuous processing including technology transfer.
  • Well versed in ICH Q8, Q9, Q10, Q11 and Q13 guidance’s, Quality by Design principles, development and implementation of enhanced approaches for project/product specific control strategies.
  • Experience in authoring relevant sections of dossier, support of PPQ/CPV, and PAI. Good understanding of theoretical and experimental approaches to advance development and application of enhanced control strategies to support RTR/RTRT opportunities, with emphasis on continuous manufacturing processes.
  • This includes demonstrated expertise in PAT method development and implementation.
  • Track record of scientific excellence and externally recognized expertise in PAT with a strong and sustained publication record in this area, for example publications, patents, conference presentations.
  • Our team is a highly collaborative group, working to tight delivery schedules, so the ability to be comfortable working at a fast, goal-oriented pace, with a team-focused approach is crucial to be successful in the role.
  • We see that the applicant is a thought leader and ideally engaged in industry/health authority forums to advance the understanding and application of advanced process control methodologies/technology.
  • Desirable requirements: Strong stakeholder management skills.
  • Experience in technology transfer and commercial manufacture using continuous processing.
  • Experience in providing support for regulatory submissions
  • Demonstrated leadership with direct management of highly skilled scientists is highly desirable.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Bending, standing, walking, lifting, sitting, carrying, stooping, crouching, kneeling repetitive motions typing- filing - writing
  • Ability to lift and carry 25 pounds
  • Travel <10%

Who We Are

ReciBioPharm hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.

Here at ReciBioPharm, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.  Are you ready to come ALIVE with a daring and intrepid team?  Don’t wait another minute; Apply today!

MEDICAL REQUIREMENTS

  • This position requires a criminal background check and drug screening.
  • COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation.

Benefits

ReciBioPharm offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits.  We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.

 

 

ReciBioPharm is an Equal Opportunity Employer.

 

Apply for this Job

* Required
resume chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
cover_letter chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Arranta Bio LLC’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Please reach out to our support team via our help center.