All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured at Alcami, such as FDA, DEA, and EU as examples. On ...
All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured at Alcami, such as FDA, DEA, and EU as examples. On ...
Director, Regulatory Affairs
Durham, NC · On-site
$135K - $179K/yr
Serves as the primary contact for all interactions with regulatory agencies such as the FDA. Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory ...
Director, Regulatory Affairs
Durham, NC · On-site
$135K - $179K/yr
Serves as the primary contact for all interactions with regulatory agencies such as the FDA. Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory ...
Practice Development Manager (BC Consumables), Allergan Aesthetics, Raleigh, NC
Raleigh, NC · On-site +1
$80K/yr
Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA GMPs. * Home office capability is required with reliable high-speed internet access. Ability to travel in order ...
Practice Development Manager (BC Consumables), Allergan Aesthetics, Raleigh, NC
Raleigh, NC · On-site +1
$80K/yr
Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA GMPs. * Home office capability is required with reliable high-speed internet access. Ability to travel in order ...
Regulatory Science Team Lead, Raleigh, NC
Raleigh, NC · On-site
$145K - $192K/yr
Also responsible for training reports and product team members on best practices for such consultations (e.g., formal meetings with the FDA) * Ensure that the regional regulatory strategy for ...
Regulatory Science Team Lead, Raleigh, NC
Raleigh, NC · On-site
$145K - $192K/yr
Also responsible for training reports and product team members on best practices for such consultations (e.g., formal meetings with the FDA) * Ensure that the regional regulatory strategy for ...
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Develop and execute phase-appropriate experimental strategies aligned with FDA CMC expectations for cell therapies (ATMPs a plus) * Partner cross-functionally with Manufacturing, MS&T, Quality ...
Develop and execute phase-appropriate experimental strategies aligned with FDA CMC expectations for cell therapies (ATMPs a plus) * Partner cross-functionally with Manufacturing, MS&T, Quality ...
Clinical Laboratory Technologist IV / V / VI #4836 #4837 #4838 #4839 #4840 #4841 ((Night Shift, Wed
$28.36 - $48.07/hr
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Quick apply
Clinical Laboratory Technologist IV / V / VI #4836 #4837 #4838 #4839 #4840 #4841 ((Night Shift, Wed
$28.36 - $48.07/hr
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA GMPs. * Home office capability is required with reliable high-speed internet access. Ability to travel in ...
Quick apply
Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA GMPs. * Home office capability is required with reliable high-speed internet access. Ability to travel in ...
Familiarity with FDA regulatory submissions and IRB processes * Experience working with industry sponsors and/or CROs Other Requirements * Proficiency with clinical research management systems (e.g ...
Familiarity with FDA regulatory submissions and IRB processes * Experience working with industry sponsors and/or CROs Other Requirements * Proficiency with clinical research management systems (e.g ...
Clinical Laboratory Technologist IV / V / VI #4836 #4837 #4838 #4839 #4840 #4841 ((Night Shift, W...
Durham, NC · On-site
$28.36 - $48.07/hr
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Clinical Laboratory Technologist IV / V / VI #4836 #4837 #4838 #4839 #4840 #4841 ((Night Shift, W...
Durham, NC · On-site
$28.36 - $48.07/hr
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Director, Regulatory Affairs
$135K - $179K/yr
Serves as the primary contact for all interactions with regulatory agencies such as the FDA. Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory ...
Director, Regulatory Affairs
$135K - $179K/yr
Serves as the primary contact for all interactions with regulatory agencies such as the FDA. Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory ...
Supervisor Clinical Laboratory # 4798 (Night Shift, Wed - Sat, 10:00pm - 8:30am)
Durham, NC · On-site
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Quick apply
Supervisor Clinical Laboratory # 4798 (Night Shift, Wed - Sat, 10:00pm - 8:30am)
Durham, NC · On-site
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Practice Development Manager (BC Consumables), Allergan Aesthetics, Raleigh, NC
Raleigh, NC · On-site
Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA GMPs. * Home office capability is required with reliable high-speed internet access. Ability to travel in order ...
Practice Development Manager (BC Consumables), Allergan Aesthetics, Raleigh, NC
Raleigh, NC · On-site
Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA GMPs. * Home office capability is required with reliable high-speed internet access. Ability to travel in order ...
Clinical Laboratory Technologist IV / V / VI #4836 #4837 #4838 #4839 #4840 #4841 ((Night Shift, ...
Durham, NC · On-site
$28.36 - $48.07/hr
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Clinical Laboratory Technologist IV / V / VI #4836 #4837 #4838 #4839 #4840 #4841 ((Night Shift, ...
Durham, NC · On-site
$28.36 - $48.07/hr
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Regulatory Science Team Lead, Raleigh, NC
$145K - $192K/yr
Also responsible for training reports and product team members on best practices for such consultations (e.g., formal meetings with the FDA) * Ensure that the regional regulatory strategy for ...
Regulatory Science Team Lead, Raleigh, NC
$145K - $192K/yr
Also responsible for training reports and product team members on best practices for such consultations (e.g., formal meetings with the FDA) * Ensure that the regional regulatory strategy for ...
Develop and execute phase-appropriate experimental strategies aligned with FDA CMC expectations for cell therapies (ATMPs a plus) * Partner cross-functionally with Manufacturing, MS&T, Quality ...
Develop and execute phase-appropriate experimental strategies aligned with FDA CMC expectations for cell therapies (ATMPs a plus) * Partner cross-functionally with Manufacturing, MS&T, Quality ...
Serve as a technical expert in QMS best practices staying abreast of evolving FDA regulations and international standards, providing guidance and interpretation to internal stakeholders. * Interface ...
Serve as a technical expert in QMS best practices staying abreast of evolving FDA regulations and international standards, providing guidance and interpretation to internal stakeholders. * Interface ...
Director, Quality Systems
Raleigh, NC · On-site
Serve as a technical expert in QMS best practices staying abreast of evolving FDA regulations and international standards, providing guidance and interpretation to internal stakeholders. * Interface ...
Director, Quality Systems
Raleigh, NC · On-site
Serve as a technical expert in QMS best practices staying abreast of evolving FDA regulations and international standards, providing guidance and interpretation to internal stakeholders. * Interface ...
Supervisor Clinical Laboratory # 4798 (Night Shift, Wed - Sat, 10:00pm - 8:30am)
Durham, NC · On-site
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
Supervisor Clinical Laboratory # 4798 (Night Shift, Wed - Sat, 10:00pm - 8:30am)
Durham, NC · On-site
IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54 ...
All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured at Alcami, such as FDA, DEA, and EU as examples. On ...
All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured at Alcami, such as FDA, DEA, and EU as examples. On ...
Fda information
See Raleigh, NC salary details
$13.01 - $18.59
11% of jobs
$23.10 is the 25th percentile. Wages below this are outliers.
$18.59 - $24.16
18% of jobs
$24.16 - $29.74
16% of jobs
The median wage is $32.53 / hr.
$29.74 - $35.32
12% of jobs
$35.32 - $40.89
11% of jobs
$45.08 is the 75th percentile. Wages above this are outliers.
$40.89 - $46.47
12% of jobs
$46.47 - $52.05
9% of jobs
$52.05 - $57.62
5% of jobs
$57.62 - $63.20
3% of jobs
$63.20 - $68.78
2% of jobs
$68.78 - $74.35
2% of jobs
$13
$38
$74
How much do fda jobs pay per hour?
Why is the FDA understaffed?
Is it hard to get hired by the FDA?
What are some typical challenges faced by professionals working at the FDA, and how can they be managed?
What are the key skills and qualifications needed to thrive as an FDA (U.S. Food and Drug Administration) Regulatory Affairs Specialist, and why are they important?
What does an FDA (Food and Drug Administration) professional do?
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What is the difference between Fda vs Food Scientist?
| Aspect | Fda | Food Scientist |
|---|---|---|
| Required Credentials | Typically a degree in health, science, or related field; certifications vary | Bachelor's or master's in food science, microbiology, or related |
| Work Environment | Regulatory agencies, laboratories, inspection sites | Food manufacturing facilities, laboratories, research settings |
| Employer & Industry Usage | U.S. Food and Drug Administration, government agencies | Food companies, research institutions, government agencies |
| Common Search & Comparison Intent | Understanding regulatory roles, compliance, and enforcement | Food safety, product development, research |
While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

Full-time
Posted 10 days ago
Alcami rating
7.3
Based on 5 frontline employees who took The Breakroom Quiz
Job description
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Are you interested in joining our team?
Job SummaryThe Sr. Manager, Facilities and Maintenance is accountable for driving results in a fast-paced environment by managing and overseeing the programs and personnel related to maintenance of the facility, process equipment, critical utilities, general facility utilities. This includes routine support of day-to-day operations as well as special projects. Special projects include customer centric projects, plant shutdowns, and facility upgrades, renovations, or expansions. The Sr. Manager, Facilities and Maintenance administers these programs and projects by assisting in the development of project plans, schedules, and provides oversight of the work during execution. All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured at Alcami, such as FDA, DEA, and EU as examples.
On-Site Expectations- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
- Provides leadership and direction to the Maintenance (GMP and Facilities).
- Plans and manages projects including facility/utility capital projects and other capital efforts.
- Ensures GMP compliance (e.g. deviation initiation and review, CAPA assignments, compliance reports, change control generation and review).
- Provides maintenance program oversight (preventative maintenance programs, repairs, spare parts program, pest control program, etc.).
- Reviews and provides oversight to the facilities maintenance work order creation, which includes troubleshooting and guidance.
- Responsible for utilities such as but not limited to HVAC, compressed air, WFI, Clean Steam, nitrogen, chilled water, etc.
- Manages bi-annual shutdowns.
- Owns site security, including maintaining the camera and badge reader systems at the site, maintaining the key control list and working with the Global Security Manager on implementation of security programs and site security plan.
- Maintains and broadcasts key metrics to management.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
- Directly supervises team of 5-8 direct reports.
- Participates in the hiring process of other employees.
- Makes hiring decisions of other employees.
- Schedules and reviews the work of other employees.
- Accountable for the curriculum assigned and timely completion of training of employees to meet regulatory requirements.
- Coaches, mentors and develops other employees.
- Prepares and delivers performance evaluations of other employees.
- Make recommendations of disciplinary actions of other employees.
- Other duties as assigned.
- Bachelor's degree (Engineering disciplines) required.
- 8 plus years of regulated (FDA, DEA, NRC, DOE, etc.) applicable experience required; 10 to 12 years preferred.
- Minimum of 4 years supervisory experience required.
- Prior pharmaceutical experience required; CMO or CDMO experience preferred.
- Experience in aseptic operations a plus.
- Expert knowledge of pharmaceutical facility operations and maintenance, and aseptic processing equipment.
- Knowledge of FDA regulated industry requirements, work order/calibration software, managing personnel, and EHS required.
- Excellent written and oral communication, coaching and mentoring skills required.
- Excellent ability to read and interpret engineering design, ability to read and understand equipment specifications and ability of track and trend data analysis required.
- Good negotiating skills required.
- Ability to manage a Maintenance team that works multiple shifts.
- Up to 10% domestic travel.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently talk or hear. The employee is required some of the time to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, knell, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.
Employment Type: FULL_TIMEAbout Alcami
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Durham, NC, US
Year founded
1979