- Together with SVP
- Work with senior management and other project team members to select and qualify CMOs/CROs
- Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK, Clinical/Regulatory, Operations, Project, etc.)
- Provide oversight during manufacture of drug products at CMOs
- Liaise with analytical contract laboratories to oversee shipping and release clinical trial supplies and to monitor drug product stability as required for clinical studies and product registration
- Work with packaging/labeling CMO to maintain adequate clinical supply inventory to support ongoing clinical studies
- Provide technical expertise to contribute to new project selection for the company
- Contribute significantly to lead selection/optimization, formulation development/process and clinical development of pipeline asset(s) selected for program advancement
- Provide support to CMC writing for regulatory submissions, board update, due diligence, etc.
- A PhD or advanced degree in Pharmaceutics, Chemical Engineering or equivalent with 10+ years of industrial experience
- Direct experience in formulation development and manufacturing of sterile solution-based drug products (experience in inhalation devices is a plus)
- Direct experience in managing clinical labeling and packaging of clinical supplies with CMOs
- Experience in managing CMC/analytical activities at different stages of drug development programs
- Have authored relevant pre-IND, IND and NDA CMC/analytical sections
- Preference will be given to candidates with direct CMC/analytical experience in approved inhalation drug products
-
Sapphire Innovations Cambridge, United StatesYour Responsibilities · As a Product Owner for Customer Experience, you will play a central role in understanding the perspectives of agencies, developers, and customers and integrating them into our product development process. · Your tasks will include analyzing customer feedba ...
-
Quantum Innovations Cambridge, United StatesAbout Somentec Software GmbH: · Since now apply, we have been distributing billing solutions for energy, water, and heat suppliers, contracting companies, and housing associations. We are firmly rooted in the industry - our customer base includes well-known companies such as Deut ...
-
Scientist Ii, Drug Product Development
3 days ago
ARIAD Boston, United States**Job ID** R0123107**Date posted** 05/16/2024**Location** Boston, MassachusettsFull time. $91,700 - $157,200 per year. · **Locations**: Boston, MA · - ** Worker Type**: Employee · - ** Worker Sub-Type**: Regular · - ** Time Type**: Full time ...
-
SPS developer product development
1 week ago
Omega Dynamics Hull, United StatesJob ID 1064 · What to expect · Development of PLC software for the latest Schenck machine generation · Continuous development and optimization of the Schenck PLC architecture · Accompaniment of prototype construction and testing of new developments until handover to series produc ...
-
Head of Product Development
1 week ago
State Street Corporation Boston, United States Full timeWho we are looking for · The Head of FX Trading Products role is responsible for defining and executing the strategic roadmap for GlobalLink's core foreign exchange trading platforms aligned with business and market needs. The role is responsible for leading a global team of bu ...
-
Custody Product Development Manager Asset
1 week ago
State Street Quincy, United States**Job Description**: · - Global Custody: Asset Servicing (Corporate Actions, Income, tax and corporate governance) - AVP level- The Product organisation is recruiting for an experienced individual covering Corporate Actions, Income, Tax and Corporate Governance supporting the Ass ...
-
Head of Product Development
1 week ago
Lovepop Boston, MA, United StatesAbout Lovepop · Lovepop is on a mission to create one billion magical moments. We combine art x engineering to create the most magical paper art cards & gifts. Featured on Shark Tank in 2015, Lovepop has become one of the top 10 Shark Tank investments in lifetime revenue. Lovepo ...
-
Director-Product Development
2 weeks ago
Boston University Boston, MA, United StatesCARB-X is seeking an expert in the research and development of prevention products to join our team at Boston University. CARB-X is a non-profit organization accelerating the pre-clinical development of drugs, vaccines and diagnostics to address antibiotic resistance. Since our l ...
-
Director-Product Development
1 day ago
Boston University Boston, MA, United StatesALLIANCE DIRECTOR (Remote - Worldwide), School of Law, CARB-X Research & Development Tracking Code Job Description CARB-X is seeking an expert in the research and development of prevention products to join our team at Boston University. CARB-X is a non-profit organization acceler ...
-
Volnay Therapeutics Cambridge, United StatesVolnay, a rapidly growing biotech with a mission to unlock innovation in cell and gene therapies, is seeking a passionate and experienced Head of Product Development and Manufacturing to join our team. In this critical leadership role, you will be responsible for designing, devel ...
-
Head of Product Development and Manufacturing
2 weeks ago
Volnay Therapeutics Cambridge, United StatesVolnay, a rapidly growing biotech with a mission to unlock innovation in cell and gene therapies, is seeking a passionate and experienced Head of Product Development and Manufacturing to join our team. In this critical leadership role, you will be responsible for designing, devel ...
-
Biogen Cambridge, MA, United StatesDirector and Head, Analytical Development (AD)- Small Molecules & Antisense Oligonucleotides will be responsible for leading the development and optimization of all analytical methods and control strategies for our portfolio of small molecules (SMs) and antisense oligonucleotides ...
-
Project Manager Product Development
1 week ago
Apex Solutions Norwood, United StatesAbout the Company · Fagus-GreCon Greten GmbH & Co. KG is a family-owned company based in Alfeld/Hannover. The GreCon brand is one of the leading brands in the production and development of fire protection, measurement, and inspection systems for various industries such as the woo ...
-
Product Development Scientist
3 days ago
actnano Malden, United StatesJob Description · Job DescriptionAbout actnano · Actnano, Inc. is a dynamic materials startup in Malden, MA. With a strong global technical team, we develop and manufacture coatings that protect printed circuit boards in electronics, allowing them to function in water-laden envi ...
-
Senior Product Development Manager
2 days ago
European Recruitment Boston, United StatesSenior Manager, Product Development - Lithium-ion Batteries · (Boston, MA - Onsite) · Are you looking for an opportunity making an active difference within the renewable energy industry? · The Senior Manager, Product Development will lead and contribute to all aspects of the deve ...
-
Senior Product Development Chemist
2 weeks ago
Unilever Boston, MA, United StatesDescription · Living Proof is seeking an innovative and motivated Senior Product Development Chemist to lead development activities of new hair care products. The Chemist will be responsible for independently planning and leading the formulation of high-performing hair care and ...
-
Avalyn Pharma Inc Cambridge, United StatesAssociate Director / Director, Product Development · Benefits: · 401(k) matching · Company parties · Competitive salary · Dental insurance · Health insurance · Opportunity for advancement · Paid time off · Parental leave · Stock options plan · Vision insurance · Wellness resour ...
-
Midea America Corp Boston, United StatesMidea America Corp., is one of the world's largest home appliance brands, offering the most comprehensive selection of products in the world to fully serve the needs of day-to-day living at home, at work, or anywhere else you go. In North America we strive to aim high, put the cu ...
-
Nexus Innovations Cochituate, United StatesBe a part of the most exciting and extensive automotive digitization projects in the OEM and supplier industry from the very beginning. We are looking for the best digital and agile minds, or those who aspire to become one. · In our team, we define the architecture and solutions ...
-
Biogen Cambridge, United StatesJob Description · Job DescriptionJob Description · This role is located in Cambridge, MA or RTP, NC. · The Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products leadership role in PO&T is responsible for the process, analytical, and technology ...
Associate Director Director Product Development - Cambridge, United States - Avalyn Pharma Inc
Description
Benefits:401(k) matching
Company parties
Competitive salary
Dental insurance
Health insurance
Opportunity for advancement
Paid time off
Parental leave
Stock options plan
Vision insurance
Wellness resources
Associate Director / Director, Product Development
Company Overview:
Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for treatment of rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
Avalyn completed an oversubscribed $175M Series C financing in September 2023 to advance our clinical-stage pulmonary fibrosis portfolio consisting of inhaled pirfenidone (AP01), inhaled nintedanib (AP02), and a fixed-dose combination of both (AP03).
Currently, treatment for IPF and PPF includes the oral antifibrotics, pirfenidone and nintedanib. Due to side effects, 30-50% of patients cannot tolerate these medications. Avalyn has developed inhaled formulations for these FDA-approved antifibrotics.AP01 has now been studied in over 150 patients with various forms of pulmonary fibrosis, over at least 48 weeks and some out to 4 years and is phase 2b ready.
PK studies show that AP01 reaches 35 times the concentration in the lung with 1/15th of the systemic concentration compared to historic oral pirfenidone.
AP01 has demonstrated efficacy in the ATLAS study, with a high dose achieving near stabilization of lung function and is well tolerated with fewer systemic adverse events vs.
historic oral pirfenidone.We have also completed a phase 1a study of AP02, an inhaled formulation of nintedanib, with phase 1b & 2 plans being developed.
Phase 1a positive topline results were announced in March 2023, and AP02 was demonstrated to be safe and well tolerated in normal volunteers & IPF patients in that study.
Position Overview:
Avalyn is seeking a highly motivated individual at the Associate Director/Director level to join its Product Development team.
This individual will play a key role in advancing Avalyn's lead AP01 program and expanding the Avalyn product pipeline to treat rare lung diseases.
This is a remote position and will be reporting to the Senior Vice President, Product Development.Key Responsibilities:
Product Development:
o develop and implement comprehensive plans to meet CMC needs that include drug substance, drug product and analytics
o plan and execute drug product manufacturing activities for the company to ensure regulatory compliance, quality and timelines are met
o plan, develop and employ project-specific CMC resource and budget plan to ensure agreed goals and spending targets are met
o participate in formulation research and product development of company pipeline product opportunities