Associate Director - Manufacturing, Drug Substance
About the job
- A Bachelor of Science degree in Engineering or Chemistry, or an equivalent combination of relevant education and applicable job experience.
- A minimum of 10 years of progressively responsible experience in the pharmaceutical or biotechnology industry, including 6 years in a leadership role.
- Contract service provider experience.
- Understanding of the biopharmaceutical drug development process, including regulatory filings, quality inspections, and audits.
- Extensive knowledge of regulations related to post-approval manufacturing process changes and site changes.
- Frequent travel to global manufacturing sites in the European Union and Asia.
- Ability to travel independently by car or airplane, domestically and internationally, up to 50% of the time, and work after hours when required by travel schedules or business issues.
- Ability to stand, walk, sit, use hands to handle objects, reach, climb or balance, stoop, kneel, crouch, see, talk, or hear in a standard office environment and independently from remote locations; occasionally lift or move up to 20 pounds.
- Oversee commercial contract manufacturing organizations and other third-party suppliers for assigned products, including transferring processes from research and development or product development to commercial third-party suppliers.
- Oversee ongoing manufacturing schedules to maintain development and commercial supply levels and meet inventory targets.
- Ensure manufacturing activities meet internal and external needs, with emphasis on process, quality, budget control, and profitability.
- Develop and maintain working relationships with contract manufacturers.
- Negotiate and manage contract manufacturing organization contracts.
- Develop standard operating procedures and work processes for commercial manufacturing.
- Work with contract manufacturers to diagnose and correct process issues.
- Identify, evaluate, and select contract manufacturers for commercial product manufacture.
- Develop and collect metrics to measure contract manufacturer performance, and lead contract manufacturer partnership teams.
- Work with the Quality Group to determine the impact of process deviations and develop resolutions.
- Develop timelines, goals, and deliverables for active pharmaceutical ingredient and related manufacturing processes.
- Optimize manufacturing processes to maintain product quality, improve process portability and robustness, increase efficiency, and reduce manufacturing costs.
- Assist in developing drug substance sourcing strategies.
- Work with Quality Assurance to ensure contract manufacturers remain current and compliant with good manufacturing practice requirements, guidelines, and procedures.
- Track supplier deviations and process changes, and collaborate with Regulatory Affairs and Quality Assurance to assess impacts on regulatory filings.
- Initiate and coordinate preparation of chemistry, manufacturing, and controls documentation as required.
- Collaborate with Regulatory Affairs and other groups to support product filings.
- Assist with contract site preparation for regulatory inspections.
- Support interdisciplinary working teams with recommendations, advice, and action plans for manufacturing-related issues.
- Provide onsite process coverage as the person-in-plant when needed.
- Communicate manufacturing or technology issues and information to company committees, teams, and interested groups.
- Supervise, train, and mentor personnel as needed.
- Participate in strategic plans for designated functions and may work with senior management to align organizational objectives.
- Develop methods, techniques, and evaluation criteria for projects, programs, and people.
- Address complex issues requiring in-depth knowledge of the functional area and related organizational objectives.
- A master's degree or Ph.D.
About the company
ACADIA Pharmaceuticals develops and commercializes medicines for central nervous system (CNS) disorders, focusing on neurological and psychiatric conditions with unmet medical needs. Its work centers on identifying drug candidates, advancing them through preclinical and clinical trials, and, upon regulatory approval, bringing therapies to market. Its products address CNS conditions such as Parkinson's disease psychosis, reflecting a commitment to treating complex brain disorders. The company combines in-house research with potential strategic collaborations to expand its portfolio and reach. Unlike peers that rely on a single development path, ACADIA emphasizes a broad pipeline and the ability to commercialize approved therapies, aiming to provide effective CNS treatments to patients and improve outcomes in mental health and neuroscience.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
San Diego, California
Founded
1993
Get referred to Acadia Pharmaceuticals
See people who can refer or advise you
Simplify's Take
What believers are saying
- August 4, 2026 revenue guidance rose to $1.24-$1.30 billion.
- DAYBUE sales hit $125 million in Q2 2026, up 30% year over year.
- FDA Fast Track and September 2026 Phase 2 topline keep remlifanserin catalyst-rich.
What critics are saying
- September 24, 2026 remlifanserin missed its Alzheimer psychosis primary endpoint, cutting shares 12.8%.
- City of Birmingham v. Acadia securities trial now advances after summary-judgment defeat.
- DAYBUE depends on Rett uptake; a 2026 Europe launch must offset any U.S. slowdown.
What makes Acadia Pharmaceuticals unique
- Acadia owns DAYBUE and NUPLAZID, the only commercial CNS franchises in its portfolio.
- September 2026 Princeton headquarters anchors East Coast operations and conference capacity.
- Fast Track remlifanserin and two Phase 2 psychosis programs deepen pipeline optionality.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
401(k) Company Match
Employee Stock Purchase Plan
Paid Vacation
Paid Holidays
Paid Sick Leave
Paid Parental Leave
Tuition Reimbursement
Growth & Insights and Company News
6 month growth
0%1 year growth
2%2 year growth
0%Ware Malcomb announces construction is complete on Acadia Pharmaceuticals' Princeton office location. PRINCETON, N.J. (September 24, 2026) - Ware Malcomb, an award-winning international design firm, announced construction is complete on a new U.S. East Coast headquarters for Acadia Pharmaceuticals Inc., located at 210 Carnegie Center in Princeton. Ware Malcomb's Princeton office provided interior architecture and design services for the two-level 62,600 SF office and biopharma workplace project. With a presence in Canada and Europe and headquartered in the U.S., Acadia Pharmaceuticals is developing and advancing treatments for neurological disorders and rare diseases, including Parkinson's disease psychosis and Rett syndrome. "We took inspiration from Acadia's brand identity and workplace design principals while tailoring the space to the layout, functionality, and character of the Princeton location. With sustainability in mind, we developed a plan that complements the space and allows the client's brand to be expressed through materials and colors," said Chelsea Chamra, Studio Manager, Interior Architecture & Design, Ware Malcomb. The space encompasses two levels of a five-story building, and the Ware Malcomb team designed an architectural connecting stair as a focal element directly off the reception area, creating a strong connection between the two floors. Through its space planning effort, the design team worked closely with the client to define a new hub and rethink how the workplace supports meetings and interactions with outside vendors and consultants. The first floor is designed to support the day-to-day workplace, incorporating executive offices, smaller meeting rooms, open work areas, a breakroom, and access to an exterior patio. The upper level takes on a more outward-facing role, functioning as a dedicated conference and training center with larger meeting spaces designed to accommodate visitors and group gatherings. The interior design draws from the natural character of the Princeton setting, incorporating biophilic principles through natural materials, daylight, and a connection to the surrounding landscape. A restrained, contemporary palette is balanced with warm textures and exposed architectural elements, creating an environment that feels sophisticated yet approachable. Linear ceiling baffles help define the spaces and create continuity across the broader floor plan, while a combination of exposed concrete, wood flooring, and natural finishes adds depth and variety throughout the interiors. The result is a cohesive workplace that reflects its setting while supporting both focused work and meaningful interaction. Color-changing lighting is incorporated throughout, a feature that allows the company to convey specific color themes correlated with announcements of new medicines or products being introduced into the market, as well as for holidays. Construction services were provided by Structure Tone. Photography credit: Cerrone Photo Established in 1972, Ware Malcomb is a dynamic, forward-thinking commercial real estate design firm providing professional architecture, interior design, civil engineering, branding, building measurement, structural engineering and MEP engineering services to clients throughout the world. With office locations throughout the United States, Canada, Mexico and Brazil, the firm specializes in the design of office, industrial, science & technology, healthcare, multifamily, retail, hospitality and public/institutional projects. The firm is also ranked among the top 10 Architecture/Engineering firms in Engineering News-Record's Top 500 Design Firms and the Top 30 Interior Design Firms in Interior Design magazine's Top 100 Giants. More than half of Fortune 500 companies are Ware Malcomb clients. For more information, visit waremalcomb.com. September 25, 2026 September 23, 2026 September 3, 2026 August 28, 2026 August 26, 2026
Ware Malcomb says construction finished on Acadia Pharmaceuticals' Princeton office. ROI-NJ Staff(Princeton) September 25, 2026 Design firm Ware Malcomb announced that construction is complete on the East Coast headquarters for Acadia Pharmaceuticals Inc., located at 210 Carnegie Center in Princeton. Ware Malcomb's Princeton office provided interior architecture and design services for the two-level 62,600-square-foot office and biopharma workplace project. Acadia Pharmaceuticals is developing and advancing treatments for neurological disorders and rare diseases, including Parkinson's disease psychosis and Rett syndrome. "We took inspiration from Acadia's brand identity and workplace design principals while tailoring the space to the layout, functionality, and character of the Princeton location. With sustainability in mind, we developed a plan that complements the space and allows the client's brand to be expressed through materials and colors," said Chelsea Chamra, studio manager, interior architecture and design, Ware Malcomb. The firm has a presence in Canada and Europe and is based in the U.S. The space spans two levels of a five-story building, and the Ware Malcomb team designed a connecting stair as a focal element directly off the reception area. Through its space planning effort, the design team worked closely with the client to define a new hub and rethink how the workplace supports meetings and interactions with outside vendors and consultants. The first floor supports day-to-day work, with executive offices, smaller meeting rooms, open work areas, a breakroom, and access to an exterior patio. The upper level functions as a dedicated conference and training center with larger meeting spaces designed to accommodate visitors and group gatherings. The interior design draws from the natural character of the Princeton setting, incorporating biophilic principles through natural materials, daylight, and a connection to the surrounding landscape. Acadia Pharmaceuticals is developing and commercializing treatments for rare and neurological disorders, with a focus on both regulatory achievements and clinical advancements.
ACADIA Pharmaceuticals (ACAD) gets 'sell' rating on weak trial results, shares fall 13%. Published September 24, 2026 at 11:26 pm EDT ACADIA Pharmaceuticals (NASDAQ:ACAD) fell for a fifth consecutive day on Thursday, shedding 12.78 percent to close at $22.18 apiece, after earning a sell recommendation from Goldman Sachs. In its market note, the investment firm reiterated its sell recommendation and $17 price target on the stock after missing its primary endpoint in its phase 2 study of 5-HT2A inverse agonist remlifanserin for the treatment of hallucinations and delusions in patients with Alzheimer's disease psychosis. The price target marked a 23 percent discount from its latest closing price. The clinical study will still progress to its third phase, but the company will be inclined to remove the 30 mg dosage arm due to the lack of improvement in its efficacy during the recently concluded trial. ACADIA Pharmaceuticals said that it plans to present detailed safety and efficacy results from the Phase 2 study in an oral presentation at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston on November 16 to 19, 2026. Additionally, remlifanserin is currently being investigated in an additional Phase 2 study to evaluate its efficacy, safety, and tolerability for the treatment of Lewy body dementia psychosis. Citi, BMO Capital maintain positive ratings. In contrast, Citigroup maintained its buy recommendation on the stock, albeit it lowered its price target to $33 from $40 previously. The reduction was also triggered by the missed primary endpoint. For its part, BMO Capital slashed its price target for the firm to $34 while maintaining an outperform rating, also amid expectations for the drug candidate's reduced probability of success to just 35 percent from 40 percent prior. BMO Capital noted that the phase 2 study trial miss represents a near-term headwind for ACADIA Pharmaceuticals, although it noted that clear response, consistency of SAPS-H+D improvements over time, and stronger efficacy in higher psychosis burden patients all suggest that the treatment candidate is therapeutically active in Alzheimer's disease psychosis. The firm said remlifanserin retains potential to show success in both Alzheimer's disease psychosis and Lewy body dementia psychosis. Strong hedge fund conviction. In terms of institutional sentiment, ACADIA Pharmaceuticals earned a strong backing from hedge fund holders, as evidenced by the jump in their committed capital, even as one fund exited its position. Data from Insider Monkey showed that 38 hedge funds held positions in the stock in the second quarter of the year, down from 39 in the quarter previously. However, the existing investors' combined holdings increased by 13.67 percent to $1.58 billion from $1.39 billion quarter-on-quarter. As the data predate phase 2 trial results, updated hedge fund holdings in the third quarter of the year will offer critical insight on whether the high-conviction buying trend persisted.
Acadia advances remlifanserin program after Phase 2 Alzheimer's trial results
Neuren secures European approval for Rett syndrome treatment. Neuren Pharmaceuticals has reached a major milestone in the global commercialisation of trofinetide after the European Commission granted marketing authorisation for DAYBU to treat neurobehavioural symptoms associated with Rett syndrome. The approval makes DAYBU the first and only authorised treatment for Rett syndrome in the European Union, extending access to patients aged five years and older across all 27 EU member states as well as Iceland, Liechtenstein and Norway. For the Melbourne-based biotechnology company, the decision represents both an important advance for families affected by the rare neurological disorder and a potentially material commercial catalyst under its licensing arrangement with Acadia Pharmaceuticals. Acadia, which holds Neuren's exclusive worldwide licence to develop and commercialise trofinetide, has previously indicated that it expects to launch DAYBU in Germany in early in the fourth quarter of 2026. Neuren chief executive Jon Pilcher said the approval was especially meaningful given the absence of an approved Rett syndrome treatment in Europe until now. "We are delighted for the Rett syndrome community in Europe, who, until now, have had no approved treatment for this devastating condition," Pilcher said. "The European Commission's approval of DAYBU is particularly rewarding for Neuren given our long-standing commitment to developing therapies for serious neurological disorders with profound unmet need." Rett syndrome is a severe genetic neurodevelopmental condition that predominantly affects girls and can lead to profound impairments in communication, motor function and everyday functioning. The European approval allows DAYBU to be marketed for the treatment of its neurobehavioural symptoms, creating a new treatment option for patients and families across the region. The decision also brings financial significance for Neuren. Under its European licence agreement with Acadia, Neuren is entitled to receive US$35 million following the first commercial sale of DAYBU in Europe. It could also receive up to US$170 million in sales milestone payments as annual net sales reach escalating thresholds, alongside tiered royalties ranging from the mid-teens to the low 20 per cent range. DAYBUE oral solution is already approved for Rett syndrome in the United States, Canada and Israel, while DAYBUE STIX powder has been approved by the US Food and Drug Administration. Trofinetide is not approved for sale in Australia. The European authorisation comes as Neuren continues to advance its broader pipeline of therapies for serious neurological disorders. Its investigational candidate NNZ-2591, also known as ercanetide, is in clinical development for several rare neurodevelopmental conditions, including Phelan-McDermid syndrome, Pitt Hopkins syndrome and Angelman syndrome. Neuren is also developing NNZ-2591 for hypoxic ischaemic encephalopathy, a form of brain injury that can occur before or shortly after birth. The company is currently running its Phase 3 Koala trial, a randomised, double blind and placebo-controlled study assessing NNZ-2591 in children aged three to 12 years with Phelan-McDermid syndrome, alongside a 52-week open-label extension study.