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External Manufacturing Lead

INTRODUCTION

Attralus is a newly established biotechnology company with novel protein therapeutics directed at systemic amyloidosis, which is responsible for a wide range of disease states that are currently underserved by currently available drugs. To meet our strategy of rapidly advancing our novel products into clinical trials and beyond, we seek the services of a Process Development/Manufacturing expert to lead critical activities within the CMC function. Reporting to the Senior Vice President, Head of CMC, the External Manufacturing Lead will provide guidance and oversight for all aspects of CMC development and cGMP activities at contract development and manufacturing organizations (CDMOs). This includes ensuring adherence to technical plans, project timelines and budget at CDMO sites for timely and uninterrupted supply of clinical trial material. The External Manufacturing Lead will work both independently and with cross-functional teams to provide high-quality support of multiple therapeutic projects. The position will function remotely, with occasional travel to Attralus’ San Francisco Bay Area home office, along with onsite work at CDMOs as appropriate and safe.

ROLES, RESPONSIBILITIES & EXPECTATIONS

  • Provides scientific expertise to design and implement innovative yet efficient solutions for the development of novel therapeutics, solving challenges and ensuring that project deliverables meet aggressive timelines
  • Coordinates product development and manufacturing activities, including, but not limited to: issuing requests for proposals for production and analytical services; participating in review and approval of contracts, work orders and change orders; supporting design and scheduling of CMC development activities and cGMP manufacturing campaigns for Drug Substance and Drug Product
  • Serves as a scientific/technical point of contact to CDMOs regarding some or all of the following: cell line development, cell culture and purification process development, formulation and drug product development, analytical method development, product and impurities characterization, cGMP manufacturing and testing, batch record review, deviation investigation, and stability studies
  • Manages relationships with contract facilities and suppliers, including communication and technical oversight, to meet accelerated timelines and to ensure timely delivery of materials to support IND-enabling studies and activities
  • Serves as an author on regulatory filings and external communications as a subject matter expert on Drug Substance development and cGMP
  • Collaborates with CMC teammates to oversee pre-clinical and clinical supply chain, including inventory and distribution of samples, reagents, intermediates and finished products
  • Ensures product integrity through diligent assessment of cGMP compliance
  • Facilitates technology transfer between contract organizations and sites when appropriate to satisfy project goals and objectives
  • Travels to contract facilities or business partners, both domestic and international, as required
  • Works on cross-functional teams to ensure effective communication between Attralus and its CDMOs and suppliers, and keeps internal stakeholders appropriately informed with CMC activities
  • Supports adherence to budgets, project plans, and performance requirements

Requirements / Qualifications

  • Bachelor's degree or higher in a scientific discipline, with a minimum of 8+ years of experience in the biotechnology or pharmaceutical industry
  • Expertise in recombinant protein drug substance process development and cGMP manufacturing, with exposure to CDMO management, is required
  • Experience with technology transfer and providing oversight to CDMOs is highly desirable
  • Experience with drug product process development and cGMP manufacturing is a plus
  • Previous authorship of CMC sections of regulatory filings associated with therapeutic proteins is essential
  • Strong understanding of cGMP, FDA and EMA guidance, ICH guidelines, and CMC content of regulatory submissions is highly desirable
  • Experience in drafting requests for proposals, review of work orders and change orders, and maintenance of budgets for manufacturing and analytical services is desirable
  • Excellent written and verbal communications skills, both internal and external, are essential
  • Excellence in teamwork, including both remote and face-to-face interactions, are also essential
  • Project management and/or team leadership experience is a plus

Does this sound like you?

Then we'd love to hear from you. Send your resume and cover letter to careers@attralus.com

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Attralus Job

AD/Director, Program Management
Attralus, Inc., (formerly Aurora Bio) is a VC funded privately held development stage biotechnology company focused on improving the lives of systemic amyloidosis patients, through the development of novel diagnostics and therapeutics...
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AD/Director, Program Management

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Overview

Attralus, Inc., (formerly Aurora Bio) is a VC funded privately held development stage biotechnology company focused on improving the lives of systemic amyloidosis patients, through the development of novel diagnostics and therapeutics. We are developing pan-amyloid targeting agents that facilitate diagnosis, and the development of novel immunotherapies designed to clear amyloid fibrils in patients with systemic amyloid diseases. We aim to improve the diagnosis and treatment of systemic amyloid diseases, such as light chain (AL), transthyretin (ATTR), and LECT2 amyloidosis, to increase patient survival and quality of life.

Attralus’ technology has broad applications and the potential to address up to 30 systemic amyloid based diseases.  Attralus has a diagnostic imaging agent currently in a ph 1/2 trial, positioned to potentially be the first approved diagnostic specifically for amyloidosis. The company also has 2 novel therapeutic fusion proteins, directed at amyloid removal, that are in pre-clinical development

Headquartered in South San Francisco and founded in 2019, Attralus has recently completed a Series A funding with VenBio to carry forward its mission to improve the lives of systemic amyloidosis patients

Description

The AD/Director, Program Management will be responsible for providing both strategic and hands-on program and project management expertise. Initially reporting directly to the CEO, the AD/Director will be responsible for creating the program plan and budget and providing daily coordination and tracking of critical activities, assuring all milestones and deliverables are met. The Director will be responsible for developing the program management processes and procedures for the company, determining appropriate software and other tools, structuring regular meetings and communication within the company and with external collaborators.

Responsibilities

Collaborate with the management team to provide project management leadership and execution activities within the company and between external partners and Attralus teams.

Develop and execute integrated cross-functional project plans with established goals, milestones, timelines and budget, with a key focus on bringing pre-clinical therapeutic programs into early clinical development

Conduct and direct day-to-day program activities to meet milestones; monitoring critical path activities to ensure delivery of program objectives.

Drive planning for key drug development milestones.

Maintain effective communication with the management team through oral and written correspondence and ensure adequate documentation of each communication. 

Always use/model/maintain/promote best practices in Program Management, including the use of agendas, minutes, dashboards, maintain document repository, establish and implement templates, tools, and processes to drive efficiency, alignment, communication, and effective planning.

Create and maintain easily accessible, high level program documents in electronic format. 

Recommend, manage and train on necessary software and tools.

Identify, develop and/or maintain an appropriate electronic platform (SharePoint, Shared Folders, etc.) for reporting/archiving/documentation of relevant program information, records, etc. 

Conduct risk management, contingency and scenario planning using appropriate program management tools.

Identify program issues or resource gaps and facilitate resolution.

Communicate program information and support development of program presentations to senior leadership, board members, investors and other key stakeholders as appropriate.

Contribute to budgetary planning at the program level.

Facilitate adherence to Aurora’s governance processes; work with key stakeholders to prepare for those interactions; lead/support as appropriate. Ensure implementation of governance decisions.

Qualifications

Minimum of a BA/BS in a scientific disciplined is required, Advance degree preferred

7+ years of program management or equivalent experience in a pharmaceutical or biotechnology organization.

Experience with research/pre-clinical and early clinical development project planning required. PM Certification is a plus.

Rare disease experience a strong plus (not required).

Desire and ability to work in a start-up, fast paced organization where you will wear many hats.

Must have excellent verbal and written communication skills as well as exceptional organizational capability.

Ability to drive program plans and timelines (across multiple functional areas) is essential.  Proven success in goal setting, prioritization and time management is required.

Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is desirable. 

Experience working with external partners is desirable.

Ability to work independently in decision-making and resolution of program obstacles and conflicts.

Familiarity with developing budgets and forecasting is desirable.

Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture.”

Have a patient-first mindset. All decisions made with patients in mind.

Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.

Benefits/Equal Opportunity Employer

Attralus, Inc. offers both comprehensive benefits and Paid Time Off (PTO) plans for employees, which begin on the first day of employment.

Attralus, Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.