Senior Scientist, Viral Vector Drug Product Formulation

King of Prussia, PA
Full Time
Process Development
Experienced
Company Overview:
SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, and the United States (CA and PA).  Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.

Position Summary:
Viral Vector Drug Product Development (VVDPD) is a department within a Technology Development Division in SKPT. VVDPD is responsible for drug product formulation, process development and nGMP pilot fill/finish for viral vectors. VVDPD represents a unique diverse team of scientists and engineers driving end-to-end Drug Product development efforts in advanced therapies. The Senior Scientist will play a critical role in the formulation development team, driving formulation screening, robustness and characterization.  This role encompasses development of de-novo early-stage formulations as well as late-stage BLA work packages in support of translation to commercialization of clients’ product. The successful candidate will be responsible for driving various activities, including, but not limited to described below:

Primary Responsibilities:
  • Design and drive formulation development and DP design for clients and internal efforts.
  • Drive innovations through evaluation of novel gene therapy formulation approaches, identification of new instrumentation and testing of emerging platforms.
  • Plan, execute and interpret formulation development experiments for various modalities of nucleic acids and non-viral delivery systems.
  • Plan and execute studies to understand and control interaction of DP with product contact material surfaces in manufacturing and clinical settings.
  • Author/review technical reports, data summaries and CMC related documents required for regulatory submissions.
  • Design and support container closure selection and development for gene therapies.
  • Contribute to technical discussions aimed at resolution of issues with suppliers, processes, and deviations
  • Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program
  • Ability to work under pressure and deliver high quality clinical trial and manufacturing batches.
  • Works closely with the MSAT team to ensure that manufacturing processes yield the highest possible DP quality profile.
  • Support with timely presentations and updates as necessary to management
  • Follow general laboratory safety and training requirements
Education & Experience:
  • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 4+ years’ experience, MS with 6+ years, BS with 8+ years.
  • Thorough understanding of formulation development, biophysical characterization, and stabilization principles.
  • Familiarity with clinical preparation and administration procedures.
  • Experience with authoring regulatory documents for IND/IMPDs and BLAs
  • Experience with formulation development of gene therapies is a plus.
  • Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
  • Attention to detail and quality are critical to success.
Physical Requirements:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Standing in a lab or manufacturing setting for more than four (4) hours when applicable.
  • Ability to lift up to 15 lbs. at times.

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.
 
Share

Apply for this position

Required*
Apply with
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • 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.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, 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?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

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.

You must enter your name and date
Human Check*