Process Development Associate

Aditi Consulting

Thousand Oaks, CA

JOB DETAILS
SALARY
$22–$23.50 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Automotive Automation, Clinical Trial, Communication Skills, Consulting, Contract Manufacturing, Cross-Functional, Data Visualization, Dosage Forms, Drug Development, Drug Products, Experiment Design, Film, GMP (Good Manufacturing Practices), Laboratory Notebook, Laboratory Operations, Maintain Compliance, Messaging Technology, Pivotal CRM, Pre-Clinical, Presentation/Verbal Skills, Process Analysis, Process Development, Product Development, Product Support, Programming Languages, Progress Reports, Purchasing/Procurement, Python Programming/Scripting Language, R Programming Language, Regulations, Risk Analysis, Safety Compliance, Safety Standards, Scripting (Scripting Languages), Short Messaging Service (SMS), Small Molecules, Speech Technology, Standard Operating Procedures (SOP), State Laws and Regulations, Supply Chain, Team Lead/Manager, Team Player, Telephony, Traceability, Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
30+ days ago
Payrate: $22.00- $23.50/hr.
 
Summary:
We are seeking an enthusiastic, motivated, and team-oriented Process Development Senior Associate, the Pre-Pivotal Drug Product Technologies organization. In this role, you will be a key member of the Oral and Enabling Delivery Systems group within the Drug Product Technologies (DPT) department. The successful candidate will be responsible for executing small molecule formulation experiments to support the development of oral solid dosage forms for early-stage clinical studies. Additionally, you will contribute to the creation and optimization of digital platform capabilities while supporting experimental efforts to design and optimize drug product formulations and processes for pre-clinical solid oral dosage forms.
 
Must Have Skills:
  • Understanding of typical unit operations for the manufacture of oral solid dosage forms, such as granulation, roller compaction, drying, milling, blending, compression, and film coating.
  • Experience with programming languages such as R and/or Python, with the ability to analyze and visualize experimental data, and familiarity with AI scripting (e.g., ChatGPT, Copilot).
  • Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.
 
Responsibilities:
  • Collaborate with cross-functional teams within DPT (e.g., Synthetic Enabling Technologies, Pivotal Synthetic Drug Product) and external functions (e.g., Drug Substance Technologies, Attribute Sciences, Supply Chain, and Contract Manufacturing) to support drug product development.
  • Develop and leverage platform capabilities, independently coordinate and analyze results, and communicate effectively in team meetings to drive formulation and process decisions.
  • Generate, collect, and document all relevant data accurately in electronic laboratory notebooks (e-LNs) to ensure compliance and traceability.
  • Maintain current knowledge of GMP regulations and SOPs, ensuring all activities adhere to regulatory and operational standards.
  • Provide scientific and risk-based evaluations of complex processes and product quality data, developing patient-centric strategies that balance business needs and innovative solutions.
  • Assist with the maintenance and upkeep of the formulations laboratory, ensuring operational readiness and compliance with safety standards.
  • Lead the creation and optimization of digital platform capabilities to streamline drug product development processes, ensuring efficient and effective formulation outcomes.
  • Deliver clear and consistent progress reports to management and cross-functional teams, keeping all stakeholders informed on project status, future plans, and program needs.
 
Pay Transparency: The typical base pay for this role across the U.S. is: $22.00- $23.50/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
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About the Company

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Aditi Consulting