Scientist I, Formulation Development

Initial Therapeutics, Inc.

California (MO)

Hybrid

USD 127,300 - 140,700

Full time

14 days+

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Benefits offered by this job

Annual bonus potential

401(k) with employer match

Wellness program + time off

Job summary

Avidity Biosciences, Inc. is seeking a Scientist I to advance the clinical and commercial formulation development of AOC drug products.

The role emphasizes stability studies of mAb and AOC forms, with responsibility for support of developability assessments and collaboration with cross-functional teams in a fast-paced TD&O environment. The successful candidate will have a strong scientific background in analytical characterization and experience with protein biologics.

Qualifications

PhD or equivalent with strong background in protein stability and formulation.
Experience with analytical biophysics and formulation development for proteins/ADCs.
Proficiency in design of experiments and data analysis.
Excellent communication and collaboration skills.

Responsibilities

Set up and conduct formulation stability studies for mAb and AOC forms.
Perform in-use compatibility studies for IV and SC delivery.
Conduct developability assessments of early-stage protein biologics.
Prepare buffers, manage lab inventory, and train staff as needed.
Collaborate with vendors and cross-functional teams; document findings clearly.
Support process development for drug substances/products as required.

Skills

Formulation development

Analytical methods

Biophysics stability

DOE/experimental design

Communication

Cross-functional collaboration

Lyophilization

Lab instrumentation

Education

PhD in chemistry/biology/pharmaceutical sciences

MS/BSc with 5–10 years industry experience

Tools

SEC

IEX

RP-HPLC

CE-SDS

cIEF

Subvisible particle analysis

MS methods for stability

Job description

Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.

Avidity Biosciences, Inc.’s mission is to profoundly improve people’s lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and X.

The Opportunity

We are seeking a highly motivated individual eager to work in a fast-paced and collaborative environment as a Scientist I within the Analytical and Formulation group of Avidity’s Technical Development and Operations (TD&O) department. This position will focus primarily on the clinical and commercial formulation development of AOC drug product and drug substance. Additional responsibilities may include but are not limited to supporting the developability assessments of early-stage mAb and AOC assets and performing in-use compatibility studies for intravenous and subcutaneous routes of administration. The successful candidate will have a strong scientific background and demonstrated experience in analytical and biophysical characterization. Experience in formulation development and stability testing of protein biologics, particularly for mAbs and antibody-drug conjugates (ADCs), is highly desirable. Strong interpersonal, organizational, and communication skills are essential as this position will require close collaboration with cross-functional team members as well as periodic communication with external research organizations and vendors. This position will report to the Principal Scientist within the Analytics and Formulation group, which is laboratory-based at the Avidity site in San Diego, CA. Non-laboratory functions such as data processing and documentation, however, may be completed remotely.

What You Will Contribute

Design and work with TD&O team members to set up and conduct formulation stability studies of mAb and AOC liquid and lyophilized dosage forms
Conduct in-use compatibility studies of AOC drug products intended for intravenous and subcutaneous routes of administration
Perform developability assessments of numerous early-stage protein biologics using a variety of predictive analytical and biophysical methods
Carry out routine lab tasks including preparing buffers, managing the inventory of laboratory consumables and supplies when needed
Work with vendors for maintenance and troubleshooting of analytical instruments
Support mAb and AOC drug substance/product process development activities when needed
Be a hands-on presence in the laboratory and support biology and chemistry departments with analytical and biophysical characterization as needed
Train lab personnel on the use of select instrumentation and methods
Specify, purchase, and manage the installation of formulation-related instrumentation and equipment
Maintain good documentation in an electronic notebook and write technical reports as required
Present data at regular team and cross functional team meetings
Contributes to the company’s core values (agile, visionary, integrated and diverse)

What We Seek

A PhD in chemistry, biology, pharmaceutical sciences, or a related field (master’s or bachelor’s degree with 5 and 10 years industry experience, respectively, will be considered).
An in-depth understanding of protein physicochemical stability, particularly how solvent conditions and cosolutes impact protein colloidal, conformational and chemical stabilities.
Hands-on experience with a variety of analytical methods including SEC, IEX, RP-HPLC, CE-SDS, cIEF and subvisible particle analysis
Experience using a variety of biophysical methods for characterizing and measuring conformational and colloidal stability of protein biologics including differential scanning calorimetry, dynamic and static light scattering techniques
Ability to design, implement and analyze formulation studies using a one-factor at a time and design of experiment (DOE) approaches using JMP statistical software or similar
Ability to multi-task and work in a fast-paced cross-functional matrix environment
Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills
Direct experience in any of the areas listed below would be viewed favorably but are not a requirement for the position:

Familiarity with mass spectrometry (MS) methods used for assessing mAb chemical stability and assessing ADC drug to antibody ratios including intact, reduced, and peptide mapping LC/MS
Prior experience in lyophilization formulation, cycle development, and analytical testing
Experience in oligonucleotide chemistry and characterization methods
Experience working with external CMOs and CROs
Previous experience managing direct reports

What We Will Provide To You:

The base salary range for this role is $127,300-$140,700. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
Avidity offers competitive compensation and benefits, which includes the opportunity for annual bonus as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Additional Details