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Principal Scientist, Formulation Development

MBX Biosciences, Inc.

United States

On-site

USD 55,000 - 80,000

Full time

12 days ago

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Job summary

A biopharmaceutical company is seeking a Principal Scientist for Formulation Development. This role involves leading formulation processes for peptide therapeutics, ensuring high product quality, and complying with industry regulations. Ideal candidates will have extensive experience in analytical development and a strong educational background in pharmaceutical sciences.

Qualifications

10+ years of relevant industrial experience in formulation and analytical development.
Demonstrated ability in peptide physicochemical stability and optimization.
Experience with analytical methods like SEC and LC-MS.

Responsibilities

Lead and optimize pharmaceutical formulations for peptide therapeutics.
Conduct stability studies and oversee quality control compliance.
Collaborate with cross-functional teams and regulatory pathways.

Skills

Analytical Method Development

Formulation Development

Quality Control

Troubleshooting Skills

Communication Skills

Education

MS or Ph.D. in pharmaceutical sciences or related field

Principal Scientist, Formulation Development

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Principal Scientist, Formulation Development

Join to apply for the Principal Scientist, Formulation Development role at MBX Biosciences, Inc.

Position Summary

The CMC Principal Scientist for Formulation and Drug Product Process Development will serve as an integral member of the CMC team at MBX Biosciences.

Position Summary

The CMC Principal Scientist for Formulation and Drug Product Process Development will serve as an integral member of the CMC team at MBX Biosciences.

We are seeking a highly skilled, experienced, and motivated individual eager to join our fast-paced and collaborative biotech environment as a Principal Scientist to lead Formulation and Drug Product Process development in MBX’s Chemistry, Manufacturing, and Controls (CMC) department. This position will focus primarily on designing, developing, and optimizing innovative pharmaceutical formulations and conducting in-depth studies to ensure product quality and performance for the peptide therapeutics in the MBX portfolio. Additional responsibilities will include supporting the developability assessments of peptide assets and designing and overseeing in-use compatibility studies, formulation screening and robustness studies, comparability studies, lyophilization cycle development, and stability studies for peptide therapeutics.

The successful candidate will have a strong scientific background and demonstrated experience in formulation development, analytical and biophysical characterization, process transfer to CDMOs, and stability studies for peptides and proteins. This role requires strong interpersonal and communication skills and will require close collaboration and strong communication with cross-functional team members as well as with external research organizations, vendors, and consultants. The CMC Principal Scientist is accountable for adherence to relevant regulatory requirements and company SOPs and will contribute to and implement industry best practices in the product development of MBX’s peptide therapeutics.

Key Responsibilities

Formulation Development: Lead and contribute to the design, development, and optimization of pharmaceutical formulations for MBX’s peptide therapeutics.
Analytical Method Development: Contribute to the development and implementation of analytical methods for characterizing peptides, including chromatographic techniques, spectroscopic techniques, and physical characterization
Quality Control and Assurance: Oversee and ensure the implementation of robust QC procedures and ensure compliance with regulatory guidance and industry standards (e.g., ICH guidelines)
Stability Studies: Plan and conduct non-GMP stability studies as part of formulation development. Contribute to the GMP stability study design to assess the shelf-life and degradation pathways.
Process Optimization: Lead and contribute to the design and execution of drug product process optimization studies, to enhance product performance and manufacturability at scale. Contribute to the process transfer to CDMOs
Troubleshooting and Investigations: Identify and address formulation and analytical technical challenges, e.g., through design experiments, root cause analyses, etc.
CMC Regulatory Compliance: Partner effectively with MBX Regulatory personnel to ensure appropriate data, information, and documentation related to formulation and analytical methods are incorporated into regulatory documents
Other responsibilities as assigned

Education, Experience, And Qualifications

MS or Ph.D. in pharmaceutical sciences, analytical chemistry, biochemistry, or related field with at least 10 years of relevant industrial experience, with a strong emphasis on formulation and analytical development
An in-depth understanding of peptide physicochemical stability, particularly for common routes of degradation, and direct experience in optimizing parenteral (liquid and lyophilized) formulations
Experience with combination products and devices is highly desirable
Hands-on experience with a variety of analytical methods, including SEC, RP-HPLC, LC-MS, and subvisible particle analysis
Prior experience in lyophilization formulation, cycle development, and analytical testing
Familiarity with end-to-end CMC drug development with an understanding of critical milestones and typical bottlenecks
CMC Regulatory knowledge, with a familiarity with regulatory requirements for parenteral drug products (e.g. FDA, EMA)
Highly motivated self-starter who works well both in teams as well as independently
Strong proven analytical and problem-solving abilities, with a track record of overcoming complex technical challenges in formulation and analytical development
Strong interpersonal & communication skills (written and oral), with the ability to develop strong collaborative working relationships with stakeholders and across technical functions, both internally and externally, to drive efficient execution of CMC technical development strategies
Strong organizational skills, ability to multi-task and work in a dynamic, fast-paced environment, with the ability to adapt to changing priorities and deadlines
Demonstrated ability to accomplish results and meet deadlines and commitments
Astute attention to detail and accuracy
Demonstrated analytical and logic skills with a focus on data-based decision-making
Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement and alignment

Company Overview

MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide (PEP) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.

EEO Statement

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Job function
Research, Analyst, and Information Technology

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