Associate Scientist I, Formulation Development

Initial Therapeutics, Inc.

California (MO)

Hybrid

USD 99,750 - 110,250

Full time

14 days+

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Benefits offered by this job

Annual bonus

401(k) with employer match

Wellness program

Four weeks time off

Job summary

Avidity Biosciences, Inc. invites applications for an Associate Scientist I in the Analytical and Formulation group, reporting to the Principal Scientist. The role focuses on clinical and commercial formulation development of AOC products, with emphasis on stability, developability, and in-use compatibility.

Hybrid work in San Diego, CA and remote options are available. You will collaborate with biology and chemistry teams, perform analytical testing (SEC, IEX, RP-HPLC, CE-SDS, cIEF), maintain

Qualifications

Bachelor’s degree in chemistry, biology, pharmaceutical sciences or related field with 5+ years industry experience.
Experience with protein physicochemical stability of mAbs.
Experience setting up formulation development and in-use studies.
Hands-on with SEC, IEX, RP-HPLC, CE-SDS, cIEF, and subvisible analysis.
Biophysical methods for stability: DSC, dynamic and static light scattering.
Strong communication and teamwork.

Responsibilities

Set up and conduct formulation stability studies for mAb and AOC products.
Perform developability assessments of early-stage protein biologics.
Prepare buffers, manage laboratory inventory, and coordinate instrument maintenance.
Conduct in-use compatibility studies for IV and subcutaneous routes.
Support process development and characterization activities.
Document results and present data at team meetings.
Lead installation of formulation instrumentation.

Skills

Analytical methods

Biophysical characterization

Protein stability

Multitasking

Communication

Education

Bachelor's degree in chemistry/biology/pharma

Master's degree in related field

Tools

SEC

IEX

RP-HPLC

CE-SDS

cIEF

Subvisible analysis

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 an Associate 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 experience in analytical and biophysical characterization, formulation development, and stability testing of protein biologics, preferably for mAbs and antibody-drug conjugates (ADCs). 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

Work with TD&O team members to set up and conduct formulation stability studies of mAb and AOC liquid and lyophilized dosage forms
Perform developability assessments of numerous early-stage protein biologics using a variety of predictive analytical and biophysical methods
Perform routine lab tasks including preparing buffers, managing the inventory of laboratory consumables and supplies, and working with vendors for maintenance and troubleshooting of analytical instruments
Conduct in-use compatibility studies of AOC drug products intended forintravenous and subcutaneous routes of administration
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
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 meetingsContributes to the company’s core values (agile, visionary, integrated and diverse)

What We Seek

A bachelor’s degree (or master’s) in chemistry, biology, pharmaceutical sciences, or a related field with a minimum of 5 years of industrial experience (3 years for a master’s degree).
An understanding of protein physicochemical stability, particularly for common routes of mAb degradation
Experience in setting up and managing formulation development and in-use compatibility studies.
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 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:

Experience using design of experiment (DOE) approaches
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

What We Will Provide To You:

The base salary range for this role is $99,750-$110,250. 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