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Senior Scientist II of Biologics Analytical Development - Chromatography

Employer
Crystal Pharmatech
Location
Cranbury, NJ
Start date
Aug 15, 2022

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Job Details

Work at CRYSTAL PHARMATECH and help develop drugs to cure human diseases!


Crystal Pharmatech is a fully integrated, CRO company advancing human therapies by providing exemplary services to biotherapeutic industry. At Crystal Pharmatech, Inc., we aim to share our beliefs and adhere to the company's core values: Integrity, Innovation, Perfection and Exceeding. We build up a learning organization that embraces learning and fosters creative and critical thinking at all levels.


Crystal Pharmatech places enormous value on people and considers team members progress and well-being to be as important as the progress of its CRO services to biotherapeutic industry. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for advancing therapeutics to cure devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology CRO service provider.  


Job Description

The successful candidate will be a leader in the development and management of chromatographic, electrophoretic and other relevant methods for the characterization and lot release of biopharmaceutical product candidates. The Senior Scientist will independently develop and qualify analytical methods to both characterize and lot release of biologics. The Senior Scientist will also effectively manage a small team of Scientists and Research Associates to carry out method development, biochemical and biophysical characterization of biologics, stability assessment, pre-formulation and formulation process development, optimization, and troubleshooting. The candidate must actively assist the biological analytical development group to communicate analytical data across multiple functional areas including analytical and formulation development, project management, and manufacturing.


Qualifications

The ideal candidate should have the following qualifications:

1. Job Requirements: Ph.D. in Chemistry / Biochemistry or in related field with 5-8+ yrs. (or masters / bachelor's degree in relevant field with 8-12+ yrs.) of relevant experience in analytical method development and structural characterization of biologics supporting CMC sections for IND, IMPD/CTA, and BLA submissions

2. 2+ years of demonstrated team leadership of Research Associates / Scientists as well as project management

3. Essential hands-on experience and in-depth knowledge of state-of-the-art instrumentation and modern analytical techniques (e.g., mass spectroscopy, peptide mapping, post-translational modifications analysis including glycosylation/oligosaccharide characterization, HPLC, capillary electrophoresis, fluorescence spectroscopy, circular dichroism, light scattering, process residuals, and Compendial assays)

4. Extensive experience with characterization of biologics (including process- & product-impurities/degradation product characterization), method development/qualification/validation, and tech transfer supporting early and late-stage development for proteins/peptides, monoclonal antibodies, protein conjugates (e.g., pegylation, etc.), antibody-drug conjugates, vaccines, etc.

5. Clear understanding of formulation development and stability studies as well as upstream/downstream processing is desired

6. Familiarity with cGMP-compliance and Quality/Regulatory Affairs, including a clear understanding of phase-appropriate CMC regulatory requirements is preferred

7. Demonstrated ability to set clear and measurable goals for staff and prioritize tasks and resources to achieve superior work quality and efficiency

8. Excellent presentation, oral and written communication skills, be able to communicate effectively to senior management, cross-functional teams, and collaborators/partners


Roles and Responsibilities

1. Mentor and manage scientists at M.S./Ph.D. level

2. Work with partners to support complex scientific projects

3. Manage projects scope, budget, and timelines


Benefits

1. PTO and Paid Sick Leave

2. Annual Bonus

3.401(K) Retirement Plan

4. Health Insurance

5. Wellness Program

6. Quarterly Project Rewards


Company

Crystal Pharmatech, Inc. is a technology driven CRO and CDMO that offers services from solid state information to processing for active pharmaceutical ingredients and formulations. We focus on formulation development and GMP manufacturing for oral dosage forms from preclinical, clinical supply and commercial drug products. Crystal Pharmatech has extensive experience selecting the appropriate solid form of a wide range of compounds for downstream formulation development. In addition, the company provides clients with data derived from experiments and partners with clients to ensure comprehensive solutions for their research needs using solid-state research and crystallization process development based on sound scientific understanding. Our formulation CDMO service provides one-stop shop for clinical supplies, starting from preformulation, to bulk manufacturing, packaging, storage and distribution to clinical sites as the destination.

Find Us
Website
Phone
609-604-8303
Location
3000 Eastpark Blvd
Suite 500B
Cranbury
New Jersey
08512
United States
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