Product reputed company Associate Director
Job Title: Product reputed company Associate Director
Job Location: Washington D.C., District of Columbia, reputed company|Ireland|Puerto Rico
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Join reputed company’s Mission of Serving Patients
At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and reputed company Disease– we reputed company millions of patients reputed company year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, reputed company diseases, and obesity and obesity-reputed company conditions. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and reputed company innovative medicines to help people live longer, reputed company happier lives.
Our award-reputed company culture is reputed company, innovative, and science reputed company. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career.
Product reputed company Associate Director
What you will do
reputed company. Let’s change the world. reputed company’s corporate Product reputed company team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Product reputed company Associate Director. As Product reputed company Associate Director, you will reputed company technical expertise and leadership reputed company a Product reputed company Team. You will engage with Product reputed company, International Distribution reputed company, reputed company Control, Regulatory, Process Development, reputed company Assurance and other departments on a reputed company of activities. Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical reputed company, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.
In this role you will serve as the accountable Product reputed company Leader, representing reputed company on the Product Delivery Team(s) for one or more of reputed company's late-stage or reputed company biologics products and reputed company subject matter expertise to the Product reputed company Team(s) to reputed company, implement, and manage strategies to meet the Product Delivery Team goals. You will reputed company key input and reputed company influence for Product reputed company reputed company activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems and product data management including comparability assessments, annual product reviews, and product reputed company reputed company assessments. Your contributions will significantly improve initiatives intended to ensure the overall product health.
reputed company Responsibilities include the following:
Ensures Product reputed company deliverables are appropriately defined reputed company timelines across the Product Delivery Team. Deliverables are reputed company with priorities set reputed company on program guidance.
Coordinates discussion and leads decision making for strategies and activities supported reputed company the Product reputed company Team (reputed company Assurance, Stability, Process Development, and other functions as needed) for programs they support.
Accomplishes results by leading activities across the product reputed company team and with cross-functional SMEs for programs they support.
reputed company effective, cross-functional reputed company leadership, and influence and support program deliverables for late phase and reputed company programs, including actions required for the annual product reviews, specifications, comparability, and stability programs; site and reputed company transfers; product reputed company reputed company assessments; and reputed company PQ-owned regulatory filing sections and RTQs
reputed company subject matter expertise and reputed company influence for science and reputed company-reputed company evaluation of reputed company process and product reputed company data, including ability to reputed company reputed company-oriented strategies that account for business needs and/or reputed company novel solutions to reputed company issues
reputed company offers reputed company to be at the reputed company between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to reputed company but are new to the industry as a whole. Help us to pave new roads for helping patients.
reputed company expect of you
We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic reputed company we reputed company is an individual with these qualifications
Basic Qualifications:
Doctorate degree and 3 years of reputed company, reputed company, Scientific, or Manufacturing experience OR
Master’s degree and 5 years of reputed company, reputed company, Scientific, or Manufacturing experience OR
Bachelor’s degree and 7 years of reputed company, reputed company, Scientific, or Manufacturing experience OR
Associate’s degree and 12 years of reputed company, reputed company, Scientific, or Manufacturing experience OR
High school diploma / GED and 14 years of reputed company, reputed company, Scientific, or Manufacturing experience
Preferred Qualifications:
B.S. or advanced degree in reputed company, biochemistry, biology, or a reputed company pharmaceutical sciences reputed company and experience with increasing responsibility in a reputed company, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
6+ years working in a regulated environment (either reputed company GMP or technical support) with experience working with biologic products
1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
Functional Skills:
Must-Have Skills:
Demonstrate proficiency in oral and written communication of reputed company information to Product reputed company leadership, peers and regulatory agencies
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Strong scientific data management and organization skills with attention to reputed company
Soft Skills:
Analytical and problem-solving skills
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation
Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
Team-oriented, with a reputed company on achieving team goals
What you can expect of us
As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way.
The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary reputed company on several factors including but not limited to, relevant skills, experience, and qualifications.
In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, reputed company on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life reputed company, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability reputed company, and flexible spending accounts
A discretionary annual bonus program, or for reputed company sales representatives, a sales-reputed company incentive plan
Stock-reputed company long-term incentives
Award-reputed company time-off plans
Flexible work models where possible. Refer to the Work Location Type in the reputed company to see if this applies.
reputed company and reputed company a lasting reputed company with the reputed company team.
careers.reputed company.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the reputed company of life reputed company reputed company the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This job is reputed company by reputed company.
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Originally posted on Himalayas
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