Sr Scientist/Prin Scientist Analytical Formulation Development

2 months ago

San Diego, United States Enlaza Therapeutics Full time

About Enlaza Therapeutics

Enlaza Therapeutics is a biotech company developing an innovative synthetic biology platform to create a unique class of biological medicines. We are dedicated to the development of treatments for serious disease and delivering these to patients.


Role Description

We are seeking a Senior Scientist/Principal Scientist with expertise in protein formulation and analytical sciences. This position will have a key role in executing internal formulation studies and contributing to analytical method development for proteins and conjugates. Additionally, this role will involve responsibilities focusing on formulation and analytics in external development and manufacturing. The ideal candidate will possess exceptional creative scientific problem-solving skills and the ability to work both independently and as part of a team. The successful candidate will have a proven record of experience that includes effective collaborations with process development/manufacturing sciences and research functions in biopharmaceutical industry setting.


Responsibilities:

·      Design and perform experiments to establish early-stage formulations for biologics, including conjugates

·      Contribute to the development of analytical methods for research and development

·      Independently design and perform forced degradation, developability/manufacturability, and stability studies

·      Analyze data and provide curated results and interpretation

·      Author and revise documents, including methods, protocols, and reports

·      Assist with external scientific activities such as guiding outsourced experiments, technical transfer, and manufacturing

·      Mentor and/or supervise junior colleagues

·      Collaborate with multiple groups to contribute expertise toward problem-solving


Required Skills and Experience:

·      Advanced degree (PhD or MS) in biophysics, biochemistry, pharmaceutical sciences, or related field

·      A minimum of 6 years post-PhD or 10 years post-MS of industry experience in therapeutic protein formulation/analytical development

·      Experience with modern equipment used for protein formulation science (Buffer exchange, DLS/MALS, DSF, DSC, turbidity, HIAC/BMI)

·      Experience performing or developing analytical methods used for release and characterization of biologic drug substance or drug product (HPLC, CE, UV-Vis)

·      Deep knowledge of protein degradation pathways, chemistry, and stability

·      Understanding of ICH guidelines

·      A strong record of increasing technical scope, responsibilities, and cross-functional impact

·      Excellent verbal, written, and presentation communication skills

·      High degree of comfort and skill with cross-functional technical interactions across job levels

·      Additional experience in the following areas is desirable but not required: Lyophilized formulation/lyo cycle development, drug product fill/finish

·      Prior experience in working with a CDMO and regulatory submissions is a plus

 

Compensation:

In addition to a competitive compensation package with stock options, the company also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.


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